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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 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
This cuff is a sterile, single use product. This part number is a 30 inch model with single port and single bladder.
Delfi Medical Innovations Inc
60-7975-105-00
In Commercial Distribution
- M995607975105003 ()
- M995607975105001 ()
- Tourniquet cuff, single-use
This cuff is a sterile, single use product. This part number is a 24 inch model with single port and single bladder.
Delfi Medical Innovations Inc
60-7975-104-00
In Commercial Distribution
- M995607975104003 ()
- M995607975104001 ()
- Tourniquet cuff, single-use
This cuff is a sterile, single use product. This part number is a 18 inch model with single port and single bladder.
Delfi Medical Innovations Inc
60-7975-103-00
In Commercial Distribution
- M995607975103003 ()
- M995607975103001 ()
- Tourniquet cuff, single-use
This cuff is a sterile, single use product. This part number is a 44 inch model with dual port and single bladder.
Delfi Medical Innovations Inc
60-7970-107-00
In Commercial Distribution
- M995607970107003 ()
- M995607970107001 ()
- Tourniquet cuff, single-use
This cuff is a sterile, single use product. This part number is a 34 inch model with dual port and single bladder.
Delfi Medical Innovations Inc
60-7970-106-00
In Commercial Distribution
- M995607970106003 ()
- M995607970106001 ()
- Tourniquet cuff, single-use
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
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
Capture-P solid phase system is intended for use in the detection of antibodies to platelets. This is the five (5) microplate product.
IMMUCOR, INC.
0066251
In Commercial Distribution
- 10888234001300 ()
0066251
- Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, agglutination
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
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
This cuff is a sterile, single use product. This part number is a 44 inch model with single port and single bladder.
Delfi Medical Innovations Inc
60-7975-107-00
In Commercial Distribution
- M995607975107003 ()
- M995607975107001 ()
- Tourniquet cuff, single-use
This cuff is a sterile, single use product. This part number is a 34 inch model with single port and single bladder.
Delfi Medical Innovations Inc
60-7975-106-00
In Commercial Distribution
- M995607975106003 ()
- M995607975106001 ()
- Tourniquet cuff, single-use
6' Electrode Lead Wire Set for use with the Uroval BRS System.
UROVAL, INC.
BR5338 UDI Not Req as is component
In Commercial Distribution
- 00852523007024 ()
- Length: 6 Feet
- Analytical non-scalp cutaneous lead
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