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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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Henry Schein - H65857003831

Spirette Mouthpiece
HENRY SCHEIN, INC.
5700383
In Commercial Distribution

  • H65857003831 ()
  • H65857003839 ()
5700383

  • Breathing mouthpiece, single-use

SURGUARD2 - 34806017512942

SURGUARD2 Safety Hypodermic Needle
TERUMO (PHILIPPINES) CORPORATION
10180094
In Commercial Distribution

  • 54806017512946 ()
  • 34806017512942 ()
  • 14806017512948 ()

  • Needle Gauge: 27 Gauge
  • Length: 0.5 Inch


  • Hypodermic needle, single-use

MaxMoreSpine - 04260200313720

Bone Curette 3.0mm
Hoogland Spine Products GmbH
1001-ABR 5
In Commercial Distribution

  • 04260200313720 ()


  • Bone curette, reusable

G&H HIGH PULL HEADCAP - 10190886000274

HIGH PULL HEADCAP SMALL
G & H Wire Company, Inc.
HPS**5
In Commercial Distribution

  • 10190886000274 ()
  • 00190886000277 ()


  • Orthodontic extraoral headgear

G&H HIGH PULL HEADCAP - 10190886000250

LARGE
G & H Wire Company, Inc.
HPL**5
In Commercial Distribution

  • 10190886000250 ()
  • 00190886000253 ()


  • Orthodontic extraoral headgear

Fisherbrand - 00613647002537

BLU 2X5 LATX FREE 36/CS
FISHER SCIENTIFIC COMPANY L.L.C.
KZ402-NO.5
In Commercial Distribution

  • 20613647002531 ()
  • 00613647002537 ()
  • 10613647002534 ()
22363123

  • Non-adhesive device retention bandage

Fisherbrand - 00613647002452

BLU 1.5X5 LATX FREE 48/CS
FISHER SCIENTIFIC COMPANY L.L.C.
KZ401.5-NO.5
In Commercial Distribution

  • 20613647002456 ()
  • 00613647002452 ()
  • 10613647002459 ()
22363112

  • Non-adhesive device retention bandage

Fisherbrand - 00613647002377

BLU 1X5 LATX FREE 30/CS
FISHER SCIENTIFIC COMPANY L.L.C.
KZ401-NO.5
In Commercial Distribution

  • 20613647002371 ()
  • 00613647002377 ()
  • 10613647002374 ()
22363101

  • Non-adhesive device retention bandage

Glooko Mobile Application - 00855093008033

The Glooko Mobile application for iOS and Android displays retrospective data that is captured from BG meters, insulin pumps and continuous glucose monitors (CGM)
GLOOKO, INC.
5.xx
In Commercial Distribution

  • 00855093008033 ()


  • Clinical management support software

Glooko Mobile Insulin Dosing System (MIDS) Android & iOS Mobile Application - 00855093008002

Glooko Mobile Insulin Dosing System (MIDS) is an insulin dose calculator. The Glooko MIDS Mobile Application is only available to patients who have been prescribed MIDS by their heath care provider. The mobile application can be downloaded by patients from the Google Play Store for Android and from the Apple App Store for iOS operating systems.
GLOOKO, INC.
5.x
In Commercial Distribution

  • 00855093008002 ()


  • Clinical management support software
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