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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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Alpha-Tec Systems - 00816085021485

PROTO-FIX with CRC bag kit
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021485 ()


  • Faecal specimen collection kit IVD, home-use

Alpha-Tec Systems - 00816085021386

PROTO-FIX with CRC 36 sets
Alpha-TEC Systems, Inc.
0
In Commercial Distribution

  • 00816085021485 ()
  • 00816085021386 ()
0004616

  • Faecal specimen collection kit IVD, home-use

FORA - 00816042014369

LANCING DEVICE with AST Cap
FORA CARE INC.
LANCING DEVICE(FORA/gojji)
In Commercial Distribution

  • 00816042014369 ()


  • Manual blood lancing device, reusable

Arthrex® - 00888867020962

KINGFISHER 220MM, WITH WISHBONE HANDLE
ARTHREX, INC.
AR-16970W
In Commercial Distribution

  • 00888867020962 ()
AR-16970W

  • Suturing unit, reusable

Surgical Direct - B382SD7043970

5.5mm Metal Cone with Ties
Surgical Direct, Inc.
SD704397
In Commercial Distribution

  • B382SD7043970 ()
SD704397

  • Laparoscopic access cannula, reusable

Arthrex® - 00888867016286

K-WIRE 1.6 MM WITH BALL
ARTHREX, INC.
AR-14016B
In Commercial Distribution

  • 00888867016286 ()
AR-14016B

  • Orthopaedic intraoperative positioning pin, single-use

Legion - 00885556790212

ANKLE CLAMP WITH LONGER ARMS
Smith & Nephew, Inc.
E0017055-1
In Commercial Distribution

  • 00885556790212 ()
E0017055-1

  • Bone approximation clamp

Trigen - 00885556781869

LAGSCREW DRIVER WITH HALL-JACOBS ADAPTER
Smith & Nephew, Inc.
E0016954-1
In Commercial Distribution

  • 00885556781869 ()
E0016954-1

  • Surgical screwdriver, reusable

LEGION - 00885556794494

ANKLE CLAMP WITH LONGER ARMS
Smith & Nephew, Inc.
E0017131-1
In Commercial Distribution

  • 00885556794494 ()
E0017131-1

  • Bone approximation clamp

LEGION - 00885556791868

ANKLE CLAMP WITH LONGER ARMS
Smith & Nephew, Inc.
E0017090-1
In Commercial Distribution

  • 00885556791868 ()
E0017090-1

  • Bone approximation clamp
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