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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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Seal® - 00840253101068

Biopsy Valve
ENDOCHOICE, INC.
SBC-460
Not in Commercial Distribution

  • 00840253101068 ()
  • 00840253101235 ()


  • Endoscope working-channel valve, reusable

Ambler Surgical - 00190660112028

Wire twister, 8 1/4'', straight, serrated jaws, spring handle
AMBLER SURGICAL CORP.
Wire twister
In Commercial Distribution

  • 00190660112028 ()
45-532

  • Surgical flat-nosed pliers

Ambler Surgical - 00190660112011

Wire twister, 7'', straight, serrated jaws, spring handle
AMBLER SURGICAL CORP.
Wire twister
In Commercial Distribution

  • 00190660112011 ()
45-531

  • Surgical flat-nosed pliers

Ambler Surgical - 00190660112004

Wire twister, 6 3/4'', straight, serrated TC jaws, spring handle
AMBLER SURGICAL CORP.
Wire twister
In Commercial Distribution

  • 00190660112004 ()
45-530

  • Surgical flat-nosed pliers

Innomed, Inc. - 00840277128027

Screw Extractor with Speedlock
INNOMED, INC.
2021
In Commercial Distribution

  • 00840277128027 ()
2021

  • Surgical flat-nosed pliers

UroLok II Adaptor - 08714729753032

Scope Adaptor
BOSTON SCIENTIFIC CORPORATION
M0067301400
In Commercial Distribution

  • 08714729066569 ()
  • 08714729753032 ()


  • Endoscope working-channel valve, single-use

RX Locking Device and Biopsy Cap - 08714729746683

Locking Device and Biopsy Cap For Use with RX Biliary System
BOSTON SCIENTIFIC CORPORATION
M00545270
In Commercial Distribution

  • 08714729296621 ()
  • 08714729746683 ()


  • Endoscope working-channel valve, single-use

RX Locking Device and Biopsy Cap - 08714729746676

Locking Device and Biopsy Cap For Use with RX Biliary System
BOSTON SCIENTIFIC CORPORATION
M00545260
In Commercial Distribution

  • 08714729296614 ()
  • 08714729746676 ()


  • Endoscope working-channel valve, single-use

RX Locking Device and Biopsy Cap - 08714729746690

Locking Device and Biopsy Cap For Use with RX Biliary System
BOSTON SCIENTIFIC CORPORATION
M00545280
In Commercial Distribution

  • 08714729296638 ()
  • 08714729746690 ()


  • Endoscope working-channel valve, single-use

Ranger™ - 08714729976257

Paclitaxel-Coated PTA Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
H74939419700480
In Commercial Distribution

  • 08714729976257 ()

  • Balloon Diameter: 7.0 Millimeter
  • Balloon Length: 40 Millimeter
  • Catheter Length: 80 Centimeter


  • Peripheral angioplasty balloon catheter, drug-coated
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