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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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Bone Splitter 2 - 08809854020033

Common Ø7.0/ L=32.8
Megagen Implant Co. Ltd
BSP02
In Commercial Distribution

  • 08809854020033 ()
BSP02

  • Surgical screwdriver, reusable

Implant Carrier - 08809854020002

Common Narrow/ Hex2.3
Megagen Implant Co. Ltd
ICNH2303
In Commercial Distribution

  • 08809854020002 ()
ICNH2303

  • Surgical screwdriver, reusable

Irix-A Lumbar Integrated Fusion System - M697T08000801

Irix A Screw Remover
Xtant Medical Holdings, Inc.
T080-0080
In Commercial Distribution

  • M697T08000800 ()
  • M697T08000801 ()


  • Surgical screwdriver, reusable

Irix-A Lumbar Integrated Fusion System - M697T08000761

Irix A Universal Joint Screwdriver
Xtant Medical Holdings, Inc.
T080-0076
In Commercial Distribution

  • M697T08000760 ()
  • M697T08000761 ()


  • Surgical screwdriver, reusable

Irix-A Lumbar Integrated Fusion System - M697T08000701

Irix A Straight Screwdriver
Xtant Medical Holdings, Inc.
T080-0070
In Commercial Distribution

  • M697T08000700 ()
  • M697T08000701 ()


  • Surgical screwdriver, reusable

1.2 HEX Driver Wrench - 08809877419722

Dental Implant Accessories - Driver
Ossvis Co., Ltd.
HHR12SW
In Commercial Distribution

  • 08809877419722 ()


  • Surgical screwdriver, reusable

NoMount Driver Engine - 08809877419715

Dental Implant Accessories - Driver
Ossvis Co., Ltd.
HNRXE
In Commercial Distribution

  • 08809877419715 ()


  • Surgical screwdriver, reusable

NoMount Driver Engine - 08809877419708

Dental Implant Accessories - Driver
Ossvis Co., Ltd.
HNRLE
In Commercial Distribution

  • 08809877419708 ()


  • Surgical screwdriver, reusable

NoMount Driver Engine - 08809877419692

Dental Implant Accessories - Driver
Ossvis Co., Ltd.
HNRSE
In Commercial Distribution

  • 08809877419692 ()


  • Surgical screwdriver, reusable

NoMount Driver Wrench - 08809877419685

Dental Implant Accessories - Driver
Ossvis Co., Ltd.
HNRXW
In Commercial Distribution

  • 08809877419685 ()


  • Surgical screwdriver, reusable
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