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This cuff is a sterile, single use product. This part number is a 30 inch model with dual port and single bladder.
Delfi Medical Innovations Inc
60-7970-105-00
In Commercial Distribution
- M995607970105003 ()
- M995607970105001 ()
- Tourniquet cuff, single-use
This cuff is a sterile, single use product. This part number is a 24 inch model with dual port and single bladder.
Delfi Medical Innovations Inc
60-7970-104-00
In Commercial Distribution
- M995607970104003 ()
- M995607970104001 ()
- Tourniquet cuff, single-use
This cuff is a sterile, single use product. This part number is an 18 inch model with dual port and single bladder.
Delfi Medical Innovations Inc
60-7970-103-00
In Commercial Distribution
- M995607970103003 ()
- M995607970103001 ()
- Tourniquet cuff, single-use
Quick Cure is intended for use as a light cure bracket adhesive.
This is a 5gm Push Syringe of Thin Viscosity Paste.
RELIANCE ORTHODONTIC PRODUCTS INC
QCT
Not in Commercial Distribution
- D798QCT0 ()
QCT
- Orthodontic bracket adhesive
BandLok is intended for use as a chemical cure band cement.
This is the 6 gm syringe of Part A, natural shade.
RELIANCE ORTHODONTIC PRODUCTS INC
BLSA
In Commercial Distribution
- D798BLSA0 ()
BLSA
- Orthodontic bracket adhesive
Excel Fast is intended for use as a bracket adhesive.
This is the Fast Set adhesive Part B in a 6gm syringe
RELIANCE ORTHODONTIC PRODUCTS INC
1EFSB
In Commercial Distribution
- D7981EFSB0 ()
1EFSB
- Orthodontic bracket adhesive
MicroCurrent Face-Lifter 6 in 1 is intended for the stimulation of neck and facial skin and is indicated for over-the-counter cosmetic use.
GESKE Beauty Tech GmbH
Magenta
In Commercial Distribution
- 04099702079632 ()
- Physical therapy transcutaneous neuromuscular electrical stimulation system
MicroCurrent Face-Lifter 6 in 1 is intended for the stimulation of neck and facial skin and is indicated for over-the-counter cosmetic use.
GESKE Beauty Tech GmbH
Green
In Commercial Distribution
- 04099702079618 ()
- Physical therapy transcutaneous neuromuscular electrical stimulation system
MicroCurrent Face-Lifter 6 in 1 is intended for the stimulation of neck and facial skin and is indicated for over-the-counter cosmetic use.
GESKE Beauty Tech GmbH
Gray
In Commercial Distribution
- 04099702079519 ()
- Physical therapy transcutaneous neuromuscular electrical stimulation system
MicroCurrent Face-Lifter 6 in 1 is intended for the stimulation of neck and facial skin and is indicated for over-the-counter cosmetic use.
GESKE Beauty Tech GmbH
Black
In Commercial Distribution
- 04099702079496 ()
- Physical therapy transcutaneous neuromuscular electrical stimulation system
MicroCurrent Face-Lifter 6 in 1 is intended for the stimulation of neck and facial skin and is indicated for over-the-counter cosmetic use.
GESKE Beauty Tech GmbH
Starlight
In Commercial Distribution
- 04099702079472 ()
- Physical therapy transcutaneous neuromuscular electrical stimulation system
NEUROTUBE is designed for primary or secondary peripheral nerve repair or reconstruction. The NEUROTUBE device is resorbed through the process of hydrolysis.
SYNOVIS MICRO COMPANIES ALLIANCE, INC
GEM0420NT
In Commercial Distribution
- 00844735006193 ()
- Length: 20 Millimeter
- Lumen/Inner Diameter: 4.0 Millimeter
531101420011
- Nerve guide, synthetic polymer, bioabsorbable
The laser system is an ophthalmologic system based on femtosecond technology. It is used to treat a wide variety of ophthalmologic indications.
Technolas Perfect Vision GmbH
3.2
In Commercial Distribution
- 04050555002895 ()
14000
- Femtosecond ophthalmic solid-state laser system
The NeoBridge is intended to anchor and support umbilical catheters. It is intended for use on pediatric (neonates, infants and children) patients.
Neotech Products LLC
Large
In Commercial Distribution
- 00812594010279 ()
- 10812594010276 ()
N702
- Wearable percutaneous catheter/tube holder
The NeoBridge is intended to anchor and support umbilical catheters. It is intended for use on pediatric (neonates, infants and children) patients.
Neotech Products LLC
Small
In Commercial Distribution
- 00812594010262 ()
- 10812594010269 ()
N701
- Wearable percutaneous catheter/tube holder
The NeoBridge is intended to anchor and support umbilical catheters. It is intended for use on pediatric (neonates, infants and children) patients.
Neotech Products LLC
Mico
In Commercial Distribution
- 00812594010170 ()
- 10812594010177 ()
N700
- Wearable percutaneous catheter/tube holder
A concentrated version of xMAP® Sheath Fluid, when diluted is is the delivery medium of the sample to the optics component.
LUMINEX CORPORATION
40-75680
In Commercial Distribution
- 00840487100103 ()
- Multiplex analyser IVD, laboratory
The Eagle device is a Q-switched, 532 nm-wavelength, frequency-doubled Nd: YAG laser that is intended for use in performing selective laser trabeculoplasty.
BELKIN VISION LTD
420840010
In Commercial Distribution
- 07290018686027 ()
- Ophthalmic solid-state laser system
The universal joint is made from stainless steel. It is used to aid in the assembly of the Integra External Fixation System.
Ascension Orthopedics, Inc.
12225221
In Commercial Distribution
- 10381780125433 ()
- 1.28 in L
12225221
- External orthopaedic fixation system, reusable
The extended compression distraction nut is manufactured from stainless steel and is used to secure components in the Integra External Fixation System.
Ascension Orthopedics, Inc.
12224216
In Commercial Distribution
- 10381780125136 ()
- .59 in H x .394 in top dia
12224216
- External orthopaedic fixation system, reusable
The non-locking compression screw is made from stainless steel and is used in conjunction with the Integra Proximal Humeral Fracture Plate System.
Ascension Orthopedics, Inc.
PSS3530CS
In Commercial Distribution
- 10381780121039 ()
- M269PSS3530CS1 ()
- 1.281 in L x .138 in dia
PSS3530CS
- Surgical soft-tissue manipulation forceps, alligator, reusable
The non-locking compression screw is made from stainless steel and is used in conjunction with the Integra Proximal Humeral Fracture Plate System.
Ascension Orthopedics, Inc.
PSS3527CS
In Commercial Distribution
- M269PSS3527CS1 ()
- 10381780121022 ()
- 1.183 in L x .138 in dia
PSS3527CS
- Orthopaedic bone screw, non-bioabsorbable, non-sterile
The non-locking compression screw is made from stainless steel and is used in conjunction with the Integra Proximal Humeral Fracture Plate System.
Ascension Orthopedics, Inc.
PSS3525CS
In Commercial Distribution
- M269PSS3525CS1 ()
- 10381780121015 ()
- 1.084 in L x .138 in dia
PSS3525CS
- Orthopaedic bone screw, non-bioabsorbable, non-sterile
The non-locking compression screw is made from stainless steel and is used in conjunction with the Integra Proximal Humeral Fracture Plate System.
Ascension Orthopedics, Inc.
PSS3522CS
In Commercial Distribution
- M269PSS3522CS1 ()
- 10381780121008 ()
- .986 in L x .138 in dia
PSS3522CS
- Orthopaedic bone screw, non-bioabsorbable, non-sterile
The non-locking compression screw is made from stainless steel and is used in conjunction with the Integra Proximal Humeral Fracture Plate System.
Ascension Orthopedics, Inc.
PSS3515CS
In Commercial Distribution
- M269PSS3515CS1 ()
- 10381780120971 ()
- .691 in L x .138 in dia
PSS3515CS
- Surgical soft-tissue manipulation forceps, alligator, reusable
The non-locking compression screw is made from stainless steel and is used in conjunction with the Integra Proximal Humeral Fracture Plate System.
Ascension Orthopedics, Inc.
PSS3540CS
In Commercial Distribution
- M269PSS3540CS1 ()
- 10381780121077 ()
- 1.675 in L x .138 in dia
PSS3540CS
- Surgical soft-tissue manipulation forceps, alligator, reusable
The non-locking compression screw is made from stainless steel and is used in conjunction with the Integra Proximal Humeral Fracture Plate System.
Ascension Orthopedics, Inc.
PSS3537CS
In Commercial Distribution
- M269PSS3537CS1 ()
- 10381780121060 ()
- 1.576 in L x .138 in dia
PSS3537CS
- Orthopaedic bone screw, non-bioabsorbable, non-sterile
The non-locking compression screw is made from stainless steel and is used in conjunction with the Integra Proximal Humeral Fracture Plate System.
Ascension Orthopedics, Inc.
PSS3535CS
In Commercial Distribution
- 10381780121053 ()
- M269PSS3535CS1 ()
- 1.478 in L x .138 in dia
PSS3535CS
- Orthopaedic bone screw, non-bioabsorbable, non-sterile
The non-locking compression screw is made from stainless steel and is used in conjunction with the Integra Proximal Humeral Fracture Plate System.
Ascension Orthopedics, Inc.
PSS3532CS
In Commercial Distribution
- M269PSS3532CS1 ()
- 10381780121046 ()
- 1.380 in L x .138 in dia
PSS3532CS
- Orthopaedic bone screw, non-bioabsorbable, non-sterile
The non-locking compression screw is made from stainless steel and is used in conjunction with the Integra Proximal Humeral Fracture Plate System.
Ascension Orthopedics, Inc.
PSS3520CS
In Commercial Distribution
- M269PSS3520CS1 ()
- 10381780120995 ()
- .887 in L x .138 in dia
PSS3520CS
- Orthopaedic bone screw, non-bioabsorbable, non-sterile
The non-locking compression screw is made from stainless steel and is used in conjunction with the Integra Proximal Humeral Fracture Plate System.
Ascension Orthopedics, Inc.
PSS3517CS
In Commercial Distribution
- M269PSS3517CS1 ()
- 10381780120988 ()
- .789 in L x .138 in dia
PSS3517CS
- Orthopaedic bone screw, non-bioabsorbable, non-sterile
The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement.
This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
Promisemed Medical Devices Inc.
ISY-7103106-100
In Commercial Distribution
- 10850011833831 ()
- 00850011833834 ()
- 80850011833830 ()
- Insulin syringe/needle, basic
The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement.
This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
Promisemed Medical Devices Inc.
ISY-8033106-100
In Commercial Distribution
- 10850011833824 ()
- 00850011833827 ()
- 80850011833823 ()
- Insulin syringe/needle, basic
The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement.
This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
Promisemed Medical Devices Inc.
ISY-8103108-100
In Commercial Distribution
- 10850011833794 ()
- 00850011833797 ()
- 80850011833793 ()
- Insulin syringe/needle, basic
The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement.
This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
Promisemed Medical Devices Inc.
ISY-8102912-100
In Commercial Distribution
- 10850011833787 ()
- 00850011833780 ()
- 80850011833786 ()
- Insulin syringe/needle, basic
The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement.
This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
Promisemed Medical Devices Inc.
ISY-8053108-100
In Commercial Distribution
- 10850011833770 ()
- 00850011833773 ()
- 80850011833779 ()
- Insulin syringe/needle, basic
The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement.
This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
Promisemed Medical Devices Inc.
ISY-8052912-100
In Commercial Distribution
- 10850011833763 ()
- 00850011833766 ()
- 80850011833762 ()
- Insulin syringe/needle, basic
The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement.
This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
Promisemed Medical Devices Inc.
ISY-8033108-100
In Commercial Distribution
- 10850011833756 ()
- 00850011833759 ()
- 80850011833755 ()
- Insulin syringe/needle, basic
The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement.
This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
Promisemed Medical Devices Inc.
ISY-7053008-100
In Commercial Distribution
- 10850011833565 ()
- 00850011833568 ()
- 80850011833564 ()
- Insulin syringe/needle, basic
The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement.
This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
Promisemed Medical Devices Inc.
ISY-7033108-100
In Commercial Distribution
- 10850011833558 ()
- 00850011833551 ()
- 80850011833557 ()
- Insulin syringe/needle, basic
The Advantage Pole is a high quality, commercial grade floor mounted support pole. The Advantage Pole is intended for moderate vertical and horizontal load bearing to provide sitting and standing support for people with reduced mobility. The Advantage Pole mast is installed to a structural floor. The maximum user weight is 450lbs / 205kgs. Note: Product is not intended to support full body weight.
Healthcraft Products Inc.
AR-AP-HD
In Commercial Distribution
- 00689281000482 ()
0048
- Freestanding support rail
Geo 3D Analog is a structure that is connected to the impression coping after the impression body is removed from the oral cavity, and is inserted into the dental plaster model. It is used to accurately replicate the location and dimensions of the fixture placed in the oral cavity during prosthesis fabrication, acting as a substitute for the actual fixture.
GEOMEDI INC.
3D-SURO
In Commercial Distribution
- 08800028704681 ()
- Dental implant analog
Geo 3D Analog is a structure that is connected to the impression coping after the impression body is removed from the oral cavity, and is inserted into the dental plaster model. It is used to accurately replicate the location and dimensions of the fixture placed in the oral cavity during prosthesis fabrication, acting as a substitute for the actual fixture.
GEOMEDI INC.
3D-SUM
In Commercial Distribution
- 08800028704674 ()
- Dental implant analog
Geo 3D Analog is a structure that is connected to the impression coping after the impression body is removed from the oral cavity, and is inserted into the dental plaster model. It is used to accurately replicate the location and dimensions of the fixture placed in the oral cavity during prosthesis fabrication, acting as a substitute for the actual fixture.
GEOMEDI INC.
3D-DER
In Commercial Distribution
- 08800028704537 ()
- Dental implant analog
The QWIX positioning screw is a cannulated screw of 7.5mm diameters. It is fully threaded and has a self-tapping tip. The screw is cannulated to enable the use of a K-Wire for an optimal positioning (2.5mm K-Wire for the 7.5mm screws). It is made from titanium alloy with anodic oxidation, and color coded according to the different diameters. It is delivered sterile.
NEWDEAL
121820SND
In Commercial Distribution
- 10381780048145 ()
- M248121820SND1 ()
- 7.5mm diam. x 120mm length
121820SND
- Orthopaedic bone screw, non-bioabsorbable, sterile
The QWIX positioning screw is a cannulated screw of 7.5mm diameters. It is fully threaded and has a self-tapping tip. The screw is cannulated to enable the use of a K-Wire for an optimal positioning (2.5mm K-Wire for the 7.5mm screws). It is made from titanium alloy with anodic oxidation, and color coded according to the different diameters. It is delivered sterile.
NEWDEAL
121815SND
In Commercial Distribution
- 10381780048138 ()
- M248121815SND1 ()
- 7.5mm diam. x 115mm length
121815SND
- Orthopaedic bone screw, non-bioabsorbable, sterile
The QWIX positioning screw is a cannulated screw of 7.5mm diameters. It is fully threaded and has a self-tapping tip. The screw is cannulated to enable the use of a K-Wire for an optimal positioning (2.5mm K-Wire for the 7.5mm screws). It is made from titanium alloy with anodic oxidation, and color coded according to the different diameters. It is delivered sterile.
NEWDEAL
121810SND
In Commercial Distribution
- 10381780048121 ()
- M248121810SND1 ()
- 7.5mm diam. x 110mm length
121810SND
- Orthopaedic bone screw, non-bioabsorbable, sterile
The QWIX positioning screw is a cannulated screw of 7.5mm diameters. It is fully threaded and has a self-tapping tip. The screw is cannulated to enable the use of a K-Wire for an optimal positioning (2.5mm K-Wire for the 7.5mm screws). It is made from titanium alloy with anodic oxidation, and color coded according to the different diameters. It is delivered sterile.
NEWDEAL
121805SND
In Commercial Distribution
- 10381780048114 ()
- M248121805SND1 ()
- 7.5mm diam. x 105mm length
121805SND
- Orthopaedic bone screw, non-bioabsorbable, sterile
The QWIX positioning screw is a cannulated screw of 7.5mm diameters. It is fully threaded and has a self-tapping tip. The screw is cannulated to enable the use of a K-Wire for an optimal positioning (2.5mm K-Wire for the 7.5mm screws). It is made from titanium alloy with anodic oxidation, and color coded according to the different diameters. It is delivered sterile.
NEWDEAL
121800SND
In Commercial Distribution
- 10381780048107 ()
- M248121800SND1 ()
- 7.5mm diam. x 100mm length
121800SND
- Orthopaedic bone screw, non-bioabsorbable, sterile
The QWIX positioning screw is a cannulated screw of 7.5mm diameters. It is fully threaded and has a self-tapping tip. The screw is cannulated to enable the use of a K-Wire for an optimal positioning (2.5mm K-Wire for the 7.5mm screws). It is made from titanium alloy with anodic oxidation, and color coded according to the different diameters. It is delivered sterile.
NEWDEAL
121795SND
In Commercial Distribution
- M248121795SND1 ()
- 10381780048091 ()
- 7.5mm diam. x 95mm length
121795SND
- Orthopaedic bone screw, non-bioabsorbable, sterile