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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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MICROTEK - 00748426113187

PACEMAKER DRAPE, 1-EACH
Microtek Medical LLC
1
In Commercial Distribution

  • 50748426113182 ()
  • 00748426113187 ()


  • Implantable cardiac monitor programmer/transmitter/alarm

SMART TSF - 00885556746370

SMART TSF.COM
Smith & Nephew, Inc.
71075401
In Commercial Distribution

  • 00885556746370 ()
71075401

  • External orthopaedic fixation frame calculation software

True Lok System - 18054242511847

TL-HEX APPLICATION SOFTWARE
ORTHOFIX SRL
01
In Commercial Distribution

  • 18054242511847 ()
TLHEXSW

  • External orthopaedic fixation frame calculation software

MEICET - 06975980570017

No Description
Shanghai May Skin Information Technology Co., Ltd.
MC10
In Commercial Distribution

  • 06975980570017 ()


  • Dermatoscopy system

MEICET - 06975980570000

No Description
Shanghai May Skin Information Technology Co., Ltd.
MC88
In Commercial Distribution

  • 06975980570000 ()


  • Dermatoscopy system

Shielded Interface Unit - 07090042055024

Shielded Interface Unit (SIU) is part of NordicNeuroLab’s fMRI System. SIU is a shielded enclosure for the Power Supply Unit, Electrostatic Energizer (audio amplifier), Optical Electrical Adapter Unit and Display Interface. SIU is used togheter with NordicNeuroLab’s Visual System and Audio System. SIU hardware configuration is dependent on the system setup and which Visual System components and Audio System components that are included in the fMRI system
Nordicneurolab AS
SIU 2.0
In Commercial Distribution

  • 07090042055024 ()


  • Medical networking interface unit

ResponseGrip Interface - 07090042054041

ResponseGrip Interface optic-electric interface unit between NordicNeuroLab’s Response Gips and stimulus presentation PC The ResponseGrip consists of two hand-held grips with two buttons each. By pressing the buttons the patient can respond to the presented stimulus. The ResponseGrip is connected to an optical-electrical adapter which converts light to electrical signals. The electrical signal is fed to the Stimulus PC by using standard PC communication interfaces.
Nordicneurolab AS
RGI-2.2
In Commercial Distribution

  • 07090042054041 ()


  • Medical networking interface unit

ResponseGrip Interface - 07090042054027

ResponseGrip Interface optic-electric interface unit between NordicNeuroLab’s Response Gips and stimulus presentation PC The ResponseGrip consists of two hand-held grips with two buttons each. By pressing the buttons the patient can respond to the presented stimulus. The ResponseGrip is connected to an optical-electrical adapter which converts light to electrical signals. The electrical signal is fed to the Stimulus PC by using standard PC communication interfaces.
Nordicneurolab AS
2.0
Not in Commercial Distribution

  • 07090042054027 ()


  • Medical networking interface unit

CADD - 15019517165753

No Description
ICU MEDICAL, INC.
21-2137-0101-25
In Commercial Distribution

  • 15019517165753 ()


  • Medical networking interface unit

CADD - 15019517173864

No Description
ICU MEDICAL, INC.
21-2131-01
In Commercial Distribution

  • 15019517173864 ()


  • Medical networking interface unit
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