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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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VICI VENOUS STENT ® SYSTEM - 00852725008096

N/A
Veniti Inc
H74912060100
In Commercial Distribution

  • 00852725008096 ()

  • Length: 100 Centimeter
  • Stent Length: 60 Millimeter
  • Stent Diameter: 12 Millimeter
H74912060100

  • Bare-metal peripheral venous stent

CareLink® Network - 00643169496460

SW CLN04 CARELINK NETWORK RELEASE
MEDTRONIC, INC.
CLN04
Not in Commercial Distribution

  • 00643169496460 ()


  • Cardiac pulse generator reader, professional

CareLink® Network - 00643169565258

SW CLN05 CARELINK NETWORK RELEASE
MEDTRONIC, INC.
CLN05
Not in Commercial Distribution

  • 00643169565258 ()


  • Cardiac pulse generator reader, professional

OBALON® - 00859810006173

OBALON® Balloon Evacuator - component for use with the OBALON® Balloon
Reshape Lifesciences Inc.
6300-0001
Not in Commercial Distribution

  • 00859810006173 ()


  • Appetite-suppression gastric balloon deployment device/set

OBALON® - 00859810006142

OBALON® Accessory Kit - Ejectors - component for use with the OBALON® Balloon
Reshape Lifesciences Inc.
6200-0001
Not in Commercial Distribution

  • 00859810006142 ()


  • Appetite-suppression gastric balloon deployment device/set

The Cologuard Plus Collection Kit - 00858637005949

No Description
EXACT SCIENCES CORPORATION
100676
In Commercial Distribution

  • 00858637005949 ()


  • Faecal specimen collection kit IVD, home-use

Cologuard Collection Kit - 00858637005017

No Description
EXACT SCIENCES CORPORATION
100026
In Commercial Distribution

  • 00858637005017 ()


  • Faecal specimen collection kit IVD, home-use

Guardian™ Link - 00643169800403

STARTER KIT MMT-7777NA GRDN LNK 1PRES US
MEDTRONIC MINIMED, INC.
MMT-7777NA
In Commercial Distribution

  • 00643169800403 ()


  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical

Abre™ - 00643169796478

STENT AB9U20150090 ABRE V01
MEDTRONIC, INC.
AB9U20150090
In Commercial Distribution

  • 00643169796478 ()

  • Stent Diameter 20 X 150 MM
  • Lumen Diameter 17.5 - 19 MM
  • Stent Length: 150.0 Millimeter
  • Minimum Sheath 9FR
  • Working Length 90 CM


  • Bare-metal peripheral venous stent

Abre™ - 00643169796461

STENT AB9U20120090 ABRE V01
MEDTRONIC, INC.
AB9U20120090
In Commercial Distribution

  • 00643169796461 ()

  • Stent Length: 120.0 Millimeter
  • Stent Diameter 20 X 120 MM
  • Minimum Sheath 9FR
  • Working Length 90 CM
  • Lumen Diameter 17.5 - 19 MM


  • Bare-metal peripheral venous stent
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