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The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single used only.
Forestadent Bernhard Förster GmbH
C737-1511
In Commercial Distribution
- EFORC7371511 ()
- Height: .022 Inch
C737-1511
- Orthodontic bracket, ceramic
The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single used only.
Forestadent Bernhard Förster GmbH
C737-1413
In Commercial Distribution
- EFORC7371413 ()
- Height: .018 Inch
C737-1413
- Orthodontic bracket, ceramic
A device that is applied to the tip of a contact type tonometer in order to avoid cross-infection between patients. The device is made of plastic. This is a single-use device.
AUTOMATED OPHTHALMICS, INC.
AO316
In Commercial Distribution
- 00860000603805 ()
- Ophthalmic tonometer tip cover
The OFC100L is a high-resolution ophthalmic imaging device that is primarily intended for photographing the fundus of the eye with / without dilating the pupil. It is a prescription-use medical device only.
Oivi AS
OFC100L
In Commercial Distribution
- 00860010826812 ()
- Ophthalmic fundus camera
The Zap-X MV Imager is designed for use with the Zap-X Radiosurgery System (“Zap-X System”) which is a computer-controlled system for performing non-invasive stereotactic radiosurgery that is self-shielded for ionizing radiation.
ZAP SURGICAL SYSTEMS, INC.
300153
In Commercial Distribution
- 00860183001535 ()
- Stereotactic radiosurgery/radiation therapy linear accelerator system
Broncoflex Vortex is a single-use video-bronchoscope which is part of a system made up of the endoscope (Broncoflex) and its reusable display monitor (Screeni). Min. purchase is 5 pcs. = 1 box
AXESS VISION TECHNOLOGY
10030001
In Commercial Distribution
- 03664977010034 ()
- 03664977110031 ()
- Lumen/Inner Diameter: 2.8 Millimeter
- Outer Diameter: 5.6 Millimeter
- Length: 605 Millimeter
10030001
- Flexible video bronchoscope, single-use
Screw Abutment Titanium Cylinder Φ5.5 Bridge
It is One-piece Cylinder. The bottom part is designed to be connected with screw abutment head part. Screw Abutment Screw (SAS18) is used to connect.
Shinhung MST Co., Ltd.
STC55B
In Commercial Distribution
- 08809458316822 ()
- 18809458316829 ()
- Outer Diameter: 5.5 Millimeter
- Length: 12 Millimeter
- Dental implant suprastructure kit
Screw Abutment Titanium Cylinder Φ4.5 Bridge
It is One-piece Cylinder. The bottom part is designed to be connected with screw abutment head part. Screw Abutment Screw (SAS18) is used to connect.
Shinhung MST Co., Ltd.
STC45B
In Commercial Distribution
- 08809458316815 ()
- 18809458316812 ()
- Outer Diameter: 4.5 Millimeter
- Length: 12 Millimeter
- Dental implant suprastructure kit
Screw Abutment Titanium Cylinder Φ4.0 Bridge
It is One-piece Cylinder. The bottom part is designed to be connected with screw abutment head part. Screw Abutment Screw (SAS18) is used to connect.
Shinhung MST Co., Ltd.
STC40B
In Commercial Distribution
- 08809458316808 ()
- 18809458316805 ()
- Outer Diameter: 4 Millimeter
- Length: 12 Millimeter
- Dental implant suprastructure kit
Screw Abutment Titanium Cylinder Φ5.5 Single
It is One-piece Cylinder. The bottom part is designed to be connected with screw abutment head part. Screw Abutment Screw (SAS18) is used to connect.
Shinhung MST Co., Ltd.
STC55S
In Commercial Distribution
- 08809458316792 ()
- 18809458316799 ()
- Outer Diameter: 5.5 Millimeter
- Length: 12 Millimeter
- Dental implant suprastructure kit
Screw Abutment Titanium Cylinder Φ4.5 Single
It is One-piece Cylinder. The bottom part is designed to be connected with screw abutment head part. Screw Abutment Screw (SAS18) is used to connect.
Shinhung MST Co., Ltd.
STC45S
In Commercial Distribution
- 08809458316785 ()
- 18809458316782 ()
- Outer Diameter: 4.5 Millimeter
- Length: 12 Millimeter
- Dental implant suprastructure kit
Screw Abutment Titanium Cylinder Φ4.0 Single
It is One-piece Cylinder. The bottom part is designed to be connected with screw abutment head part. Screw Abutment Screw (SAS18) is used to connect.
Shinhung MST Co., Ltd.
STC40S
In Commercial Distribution
- 08809458316778 ()
- 18809458316775 ()
- Outer Diameter: 4 Millimeter
- Length: 12 Millimeter
- Dental implant suprastructure kit
Removal aid is a plastic clamp that is pressed together by finger force to clamp the HME at HME removal from the speaking devices. Removal Aid is for single patient re-use.
Atos Medical AB
7745
In Commercial Distribution
- 07331791016523 ()
- 07331791008221 ()
7745
- Tracheostoma protective filter
The QWIX® 4.3 mm screw rack is part of the container which product number is 299910ND and that is used for transport and sterilization of instruments and non sterile implants.
NEWDEAL
299926ND
Not in Commercial Distribution
- M248299926ND1 ()
- 10381780042563 ()
- Device sterilization/disinfection container, reusable
The QWIX® 3.0 mm screw rack is part of the container which product number is 299910ND and that is used for transport and sterilization of instruments and non sterile implants.
NEWDEAL
299925ND
Not in Commercial Distribution
- M248299925ND1 ()
- 10381780042556 ()
- Device sterilization/disinfection container, reusable
The SURFIX® 3.0 mm screw rack is part of the container which product number is 299910ND and that is used for transport and sterilization of instruments and non sterile implants.
NEWDEAL
299922ND
Not in Commercial Distribution
- M248299922ND1 ()
- 10381780042525 ()
- Device sterilization/disinfection container, reusable
The SURFIX® 2.7 mm screw rack is part of the container which product number is 299910ND and that is used for transport and sterilization of instruments and non sterile implants.
NEWDEAL
299921ND
Not in Commercial Distribution
- M248299921ND1 ()
- 10381780042518 ()
- Device sterilization/disinfection container, reusable
The Alumi-Hand is the unique, ready-to-use hand immobilizer. Sterile and disposable, the Alumi-Hand is ready to go. Made of aluminum, the Alumi-Hand is Lead-Free, Latex-Free, and X-ray compatible. Box or 8
INSTRUMENT SPECIALISTS, INC.
Large
In Commercial Distribution
- 00810045920030 ()
760-8
- Limb/torso/head restraint, single-use
The Alumi-Hand is the unique, ready-to-use hand immobilizer. Sterile and disposable, the Alumi-Hand is ready to go. Made of aluminum, the Alumi-Hand is Lead-Free, Latex-Free, and X-ray compatible. Box or 8
INSTRUMENT SPECIALISTS, INC.
Extra Large
In Commercial Distribution
- 00810045920023 ()
761-8
- Limb/torso/head restraint, single-use
The Registration Pointer EM-D is an electromagnetically tracked instrument with a rounded, blunt tip that is used to register the patient anatomy. The location of the instrument is referenced relative to a patient tracker affixed to the patient’s anatomy. The pointer connects to the Hybrid Navigation Unit EM via an integrated cable.
The Precision Pointer EM-D is provided non-sterile and is intended intended for high-level disinfection only. It is intended to be used prior to surgical draping while the patient environment is not covered under sterile drape. The Registration Pointer EM-D is reusable.
Scopis GmbH
1.0
In Commercial Distribution
- B057U1029030 ()
U1 029 03
- Electromagnetic surgical navigation device tracking system
The Integra Movement Great Toe System phalangeal component is designed for resurfacing the base of the proximal phalanx. The component is an anatomically designed, monolithic device. The device is made from cobalt chromium alloy with a commerically pure titanium plasma spray. The phalangeal component is intended as hemi-arthroplasty at the surface and is press-fit.
Ascension Orthopedics, Inc.
MGT89040PPH
In Commercial Distribution
- 10381780116479 ()
- M268MGT89040PPH1 ()
- .771 in L x .549 in W x .472 in H; Size 40
MGT89040PPH
- Partial metatarsophalangeal joint prosthesis
The Integra Movement Great Toe System phalangeal component is designed for resurfacing the base of the proximal phalanx. The component is an anatomically designed, monolithic device. The device is made from cobalt chromium alloy with a commerically pure titanium plasma spray. The phalangeal component is intended as hemi-arthroplasty at the surface and is press-fit.
Ascension Orthopedics, Inc.
MGT89030PPH
In Commercial Distribution
- 10381780116455 ()
- M268MGT89030PPH1 ()
- .721 in L x .520 in W x .433 in H; Size 30
MGT89030PPH
- Partial metatarsophalangeal joint prosthesis
The Integra Movement Great Toe System phalangeal component is designed for resurfacing the base of the proximal phalanx. The component is an anatomically designed, monolithic device. The device is made from cobalt chromium alloy with a commerically pure titanium plasma spray. The phalangeal component is intended as hemi-arthroplasty at the surface and is press-fit.
Ascension Orthopedics, Inc.
MGT89020PPH
In Commercial Distribution
- 10381780116431 ()
- M268MGT89020PPH1 ()
- .660 in L x .492 in W x .394 in H; Size 20
MGT89020PPH
- Partial metatarsophalangeal joint prosthesis
The Integra Movement Great Toe System phalangeal component is designed for resurfacing the base of the proximal phalanx. The component is an anatomically designed, monolithic device. The device is made from cobalt chromium alloy with a commerically pure titanium plasma spray. The phalangeal component is intended as hemi-arthroplasty at the surface and is press-fit.
Ascension Orthopedics, Inc.
MGT89010PPH
In Commercial Distribution
- 10381780116417 ()
- M268MGT89010PPH1 ()
- .606 in L x .463 in W x .354 in H; Size 10
MGT89010PPH
- Partial metatarsophalangeal joint prosthesis
The 1.2mL Skyrizi On-Body Injector is designed to be used in conjunction with a pre-filled cartridge assembly containing a 180mg/1.2mL dose of risankizumab-rzaa drug product. The single use device is designed for subcutaneous injection. The device is pre-sterilized and pre-programmed. The device is co-packaged with the drug product and is not marketed separately.
ABBVIE INC.
19558594
In Commercial Distribution
- 48054083023968 ()
- Width: 41 Millimeter
- Length: 85 Millimeter
- Height: 22.5 Millimeter
19558594
- Subcutaneous self-injection aid
The 2.4mL Skyrizi On-Body Injector is designed to be used in conjunction with a pre-filled cartridge assembly containing a 360mg/2.4mL dose of risankizumab-rzaa drug product. The single use device is designed for subcutaneous injection. The device is pre-sterilized and pre-programmed. The device is co-packaged with the drug product and is not marketed separately.
ABBVIE INC.
19558595
In Commercial Distribution
- 48054083023234 ()
- Width: 41 Millimeter
- Length: 85 Millimeter
- Height: 22.5 Millimeter
- Subcutaneous self-injection aid
Hook, in combination with the slap hammer, is intended to help the surgeon to pull/liberate the components in area where the access, due to soft tissues, is limited. When the instrument is placed at the femoral distal trochlea groove, it is ideal for pulling off the femoral implant. This is a reusable device.
MPS Micro Precision Systems AG
T14587
In Commercial Distribution
- 07640187910490 ()
T14587
- Orthopaedic inorganic implant inserter/extractor, reusable
REPOSITIONING SLEEVE
ST. JUDE MEDICAL, INC.
406503
In Commercial Distribution
- 05414734030052 ()
- 15414734030059 ()
- Length: 60 Centimeter
406503
- Cardiovascular catheter sheath
This is sold as part of the 11-Unit Packages for Lucitone 199 and Hy-Pro Lucitone. It is not sold separately.
Dentsply International Inc.
Liquid
In Commercial Distribution
- D0016843050 ()
- Total Volume: 120 Milliliter
- Dental appliance fabrication material, resin
Fibered Light. This is part of the Hy-Pro Lucitone 11-Unit Package Fibered Light (684406) only. It is not sold separately.
Dentsply International Inc.
Denture Base Powder
Not in Commercial Distribution
- D0019844100 ()
- Weight: 231 Gram
- Dental appliance fabrication material, resin
Fibered Dark. This is part of the Hy-Pro Lucitone 11-Unit Package Fibered Dark (684175) only. It is not sold separately.
Dentsply International Inc.
Denture Base Powder
Not in Commercial Distribution
- D0019841660 ()
- Weight: 231 Gram
- Dental appliance fabrication material, resin
Light Fibered. This is sold as part of the Dentsply Repair Material Starter Pack 680050. It is not sold seperately.
Dentsply International Inc.
Powder
Not in Commercial Distribution
- D0019800540 ()
- Weight: 21 Gram
- Dental appliance fabrication material, resin
Pink Fibered. This is sold as part of the Dentsply Repair Material Starter Pack 680050. It is not sold seperately.
Dentsply International Inc.
Powder
Not in Commercial Distribution
- D0019800530 ()
- Weight: 21 Gram
- Dental appliance fabrication material, resin
NetCom Client is an application programming interface (API) that is intended to allow data transfer to/from the Pegasus software.
NEURALYNX, INC.
3.1.0
In Commercial Distribution
- 00850011306673 ()
36-0301-0004
- Electroencephalographic monitoring system
Electro Lube is a single patient use device that is intended to be used on electrosurgical electrodes to reduce sticking.
KEY SURGICAL, INC.
EL101
EL101
- Electrosurgical electrode lubricant
Electro Lube is a single patient use device that is intended to be used on electrosurgical electrodes to reduce sticking.
KEY SURGICAL, INC.
EL-101
Not in Commercial Distribution
- 10849771037870 ()
- 00849771037873 ()
- Total Volume: 4 Milliliter
EL101
- Electrosurgical electrode lubricant
Swift® applicator tip is provided as a single-use, non-sterile disposable tip, which is connected to the Swift® handpiece.
EMBLATION LIMITED
SWF-ATO1
In Commercial Distribution
- 05060652910039 ()
SWF-ATO1
- Intraoperative gamma radiation detection system probe cover
The device is the Phillips 0.9mm RX Turbo Elite Laser Atherectomy catheter that is reprocessed by Northeast Scientific, Inc. (NES)
NORTH EAST SCIENTIFIC INC
R-410-154
In Commercial Distribution
- 00850044399062 ()
- B227NRP1300 ()
- Catheter Working Length: 150 Centimeter
- Lumen/Inner Diameter: 0.014 Inch
- Introducer Sheath Compatibility: 4 French
R-410-154
- Atherectomy laser system beam guide-catheter, peripheral
The device FlexPointer is a navigation probe for image guided surgery.
The device is component to the Cube4D Navigation system.
Fiagon GmbH
E012002
E012002
- Multi-purpose stereotactic surgery system
White color handle, Oval, 1*7 wire,Diameteris 30 mm,outer diameter is 2.54mm , working length is 1600mm,working channel2.8mm
Micro-Tech (Nanjing) Co., Ltd.
NT-E-30/16-P
In Commercial Distribution
- 16932503554524 ()
- 06932503554527 ()
- 26932503554521 ()
- 56932503554522 ()
- 66932503554529 ()
- Outer Diameter: 2.54 Millimeter
- Length: 160 Centimeter
- Endoscope working-channel valve, single-use
White color handle, Oval, 1*7 wire,Diameteris 30 mm,outer diameter is 2.54mm,working length is 2300mm,working channel2.8mm
Micro-Tech (Nanjing) Co., Ltd.
NT-E-30/23-P
In Commercial Distribution
- 16932503554517 ()
- 06932503554510 ()
- 26932503554514 ()
- 56932503554515 ()
- 66932503554512 ()
- Outer Diameter: 2.54 Millimeter
- Length: 230 Centimeter
- Endoscope working-channel valve, single-use
The endoscope with a diameter of 12.8-14.5mm is available. The product is standard type of Embrella™ Endoscopic Distal Attachment .
Micro-Tech (Nanjing) Co., Ltd.
EM-S-01
In Commercial Distribution
- 16932503560822 ()
- 06932503560825 ()
- 26932503560829 ()
- Colonoscope distal anchoring cuff
The endoscope with a diameter of 11.5-13mm is available. The product is standard type of Embrella™ Endoscopic Distal Attachment .
Micro-Tech (Nanjing) Co., Ltd.
EM-S-02
In Commercial Distribution
- 16932503560815 ()
- 06932503560818 ()
- 26932503560812 ()
- Colonoscope distal anchoring cuff
The Perfusion Clamp is used for explanted organ recovered with aortic patch. It is a sterile, disposable and single-use device.
INSTITUT GEORGES LOPEZ
PC1025A
In Commercial Distribution
- 23700911900949 ()
- 13700911900942 ()
- 53700911900940 ()
- 33700911900946 ()
- Kidney donor-organ preservation/transport perfusion set
The Perfusion Clamp is used for explanted organ recovered with aortic patch. It is a sterile, disposable and single-use device.
INSTITUT GEORGES LOPEZ
PC715A
In Commercial Distribution
- 23700911900932 ()
- 13700911900935 ()
- 53700911900933 ()
- 33700911900939 ()
- Kidney donor-organ preservation/transport perfusion set
The Perfusion Clamp is used for explanted organ recovered with aortic patch. It is a sterile, disposable and single-use device.
INSTITUT GEORGES LOPEZ
PC1020A
In Commercial Distribution
- 23700911900925 ()
- 13700911900928 ()
- 53700911900926 ()
- 33700911900922 ()
- Kidney donor-organ preservation/transport perfusion set
The Perfusion Clamp is used for explanted organ recovered with aortic patch. It is a sterile, disposable and single-use device.
INSTITUT GEORGES LOPEZ
PC715
In Commercial Distribution
- 23700911900642 ()
- 13700911900645 ()
- Kidney donor-organ preservation/transport perfusion set
The Perfusion Clamp is used for explanted organ recovered with aortic patch. It is a sterile, disposable and single-use device.
INSTITUT GEORGES LOPEZ
PC1025
In Commercial Distribution
- 23700911900635 ()
- 13700911900638 ()
- Kidney donor-organ preservation/transport perfusion set
The Perfusion Clamp is used for explanted organ recovered with aortic patch. It is a sterile, disposable and single-use device.
INSTITUT GEORGES LOPEZ
PC1020
In Commercial Distribution
- 23700911900628 ()
- 13700911900621 ()
- Kidney donor-organ preservation/transport perfusion set
The DGH2006 is an angled corded probe containing an ultrasonic transducer. This probe is used with DGH ultrasonic pachymeter devices.
DGH TECHNOLOGY INC.
DGH 2006
In Commercial Distribution
- 00857377006216 ()
- Ophthalmic ultrasound imaging transducer