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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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Oticon - 05707131131041

M60, ITC/ITE AT BE
Oticon A/S
106-71-290-10
In Commercial Distribution

  • 05707131131041 ()


  • Air-conduction hearing aid, in-the-ear

Brasseler USA - 00887919676393

AT STILL PORC EX-ORAL ADJUST
Peter Brasseler Holdings, LLC
5022808U0
In Commercial Distribution

  • 00887919676393 ()


  • Diamond dental bur, single-use

Brasseler USA - 00887919676355

AT STILL DIALITE PORC POLISH
Peter Brasseler Holdings, LLC
5022804U0
In Commercial Distribution

  • 00887919676355 ()


  • Diamond dental bur, single-use

CARDINAL HEALTH - 10197106832639

SC AT PELHAM LAP PACK
Cardinal Health 200, LLC
SBA23LAPL1
In Commercial Distribution

  • 50197106832637 ()
  • 10197106832639 ()
SBA23LAPL1

  • General surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 00810010892300

AT HOME STOOL COLLECTION KIT
AERO-MED, LLC
AMM1960FIT
In Commercial Distribution

  • 00810010892300 ()
AMM1960FIT

  • General specimen transport medium collection kit, non-sterile

CARDINAL HEALTH - 10197106643044

SC AT PELHAM EXTREMITY PACK
Cardinal Health 200, LLC
SOP23EPPL4
In Commercial Distribution

  • 50197106643042 ()
  • 10197106643044 ()
SOP23EPPL4

  • Orthopaedic surgical procedure kit, non-medicated, single-use

QG-TV-IP-FM - 60889976573341

QG-TV10-IPF-MAT TECHVISION QS-550 DRX AT
CARESTREAM HEALTH, INC.
QG-TV-IP-FM
In Commercial Distribution

  • 60889976573341 ()
6573349

  • X-ray system computer, diagnostic, general-purpose

QG-TV-IP-CM - 60889976573327

QG-TV10-IPC-MAT TECHVISION RS-590 DRX AT
CARESTREAM HEALTH, INC.
QG-TV-IP-CM
In Commercial Distribution

  • 60889976573327 ()
6573323

  • X-ray system computer, diagnostic, general-purpose

AIR-FLOW - 07613353064853

AIR-FLOW Handpiece Blue at 120°
E.M.S. Electro Medical Systems S.A.
c
In Commercial Distribution

  • 07613353064853 ()
EL-308/B

  • Dental abrasive air jet system

AIR-FLOW - 07613353002534

AIR-FLOW Handpiece Grey at 120°
E.M.S. Electro Medical Systems S.A.
c
In Commercial Distribution

  • 07613353002534 ()
EL-308/A

  • Dental abrasive air jet system

VeriQuick - 00049696737845

At Home Marijuana Test Kit
FOURSTAR GROUP INC.
11012637
In Commercial Distribution

  • 00049696737845 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)

VeriQuick - 00049696736664

At Home Marijuana Test Kit
FOURSTAR GROUP INC.
11012637
In Commercial Distribution

  • 00049696736664 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)

VeriQuick - 00049696712675

At Home Marijuana Drug Test
FOURSTAR GROUP INC.
11012637B
In Commercial Distribution

  • 00049696712675 ()


  • Moist-heat pack

AIR-FLOW - 07613353198671

AIR-FLOW Handpiece White at 120°
E.M.S. Electro Medical Systems S.A.
EL-308HF/C
In Commercial Distribution

  • 07613353198671 ()


  • Dental abrasive air jet system

AIR-FLOW - 07613353166069

AIR-FLOW Handpiece White at 120°
E.M.S. Electro Medical Systems S.A.
C
In Commercial Distribution

  • 07613353166069 ()
EL-308HF/C

  • Dental abrasive air jet system

AIR-FLOW - 07613353064976

AIR-FLOW Handpiece White at 120°
E.M.S. Electro Medical Systems S.A.
A
In Commercial Distribution

  • 07613353064976 ()
EL-308#HF/A/001

  • Dental abrasive air jet system

AIR-FLOW - 07613353064877

AIR-FLOW Handpiece White at 120°
E.M.S. Electro Medical Systems S.A.
c
In Commercial Distribution

  • 07613353064877 ()
EL-308/C

  • Dental abrasive air jet system

AIR-FLOW - 07613353002473

AIR-FLOW Handpiece White at 120°
E.M.S. Electro Medical Systems S.A.
B
In Commercial Distribution

  • 07613353002473 ()
EL-308HF/C

  • Dental abrasive air jet system

CARDINAL HEALTH - 10195594825041

SC AT PELHAM EXTREMITY PACK
Cardinal Health 200, LLC
SOP23EPPL3
In Commercial Distribution

  • 50195594825049 ()
  • 10195594825041 ()
SOP23EPPL3

  • Orthopaedic surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10195594188054

SC AT PELHAM LAP PACK
Cardinal Health 200, LLC
SBA23LAPLA
In Commercial Distribution

  • 50195594188052 ()
  • 10195594188054 ()
SBA23LAPLA

  • General surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10195594340780

SC AT PELHAM EXTREMITY PACK
Cardinal Health 200, LLC
SOP23EPPL2
In Commercial Distribution

  • 50195594340788 ()
  • 10195594340780 ()
SOP23EPPL2

  • Orthopaedic surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10195594226763

SC AT PELHAM EXTREMITY PACK
Cardinal Health 200, LLC
SOP23EPPL1
In Commercial Distribution

  • 50195594226761 ()
  • 10195594226763 ()
SOP23EPPL1

  • Orthopaedic surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10195594374563

SC AT PELHAM LAP PACK
Cardinal Health 200, LLC
SBA23LAPLB
In Commercial Distribution

  • 50195594374561 ()
  • 10195594374563 ()
SBA23LAPLB

  • General surgical procedure kit, non-medicated, single-use

CARDINAL HEALTH - 10195594373801

SC AT PELHAM EXTREMITY PACK
Cardinal Health 200, LLC
SOP23EPPLB
In Commercial Distribution

  • 50195594373809 ()
  • 10195594373801 ()
SOP23EPPLB

  • Orthopaedic surgical procedure kit, non-medicated, single-use

ACCUTRANS™ Disposable Pressure Monitoring System - 08886483503854

No Description
BIOPTIMAL INTERNATIONAL PTE. LTD.
AT 4812-3
In Commercial Distribution

  • 08886483503854 ()
22-000942-03

  • Invasive blood pressure transducer set

Unistik Pro - 00384701644016

Unistik Pro Safety Lancet - 28G x 1.2mm
OWEN MUMFORD LIMITED
AT 1644
In Commercial Distribution

  • 00384701644030 ()
  • 00384701644016 ()
  • 00384701644009 ()

  • Needle Gauge: 28 Gauge
  • Depth: 1.2 Millimeter


  • Manual blood lancing device, single-use

Unistik Pro - 00384701634017

Unistik Pro Safety Lancet - 25G x 1.6mm
OWEN MUMFORD LIMITED
AT 1634
In Commercial Distribution

  • 00384701634031 ()
  • 00384701634017 ()
  • 00384701634000 ()

  • Needle Gauge: 25 Gauge
  • Depth: 1.6 Millimeter


  • Manual blood lancing device, single-use

Unistik Pro - 00384701614019

Unistik Pro Safety Lancet - 21G x 2.0mm
OWEN MUMFORD LIMITED
AT 1614
In Commercial Distribution

  • 00384701614033 ()
  • 00384701614019 ()
  • 00384701614002 ()

  • Needle Gauge: 21 Gauge
  • Depth: 2.0 Millimeter


  • Manual blood lancing device, single-use

Unistik Touch - 00384701464010

Unistik Touch contact activated safety lancet - 16G x 2.0mm, highest flow.
OWEN MUMFORD LIMITED
AT 1464
In Commercial Distribution

  • 00384701464034 ()
  • 00384701464010 ()
  • 00384701464003 ()

  • Needle Gauge: 16 Gauge


  • Manual blood lancing device, single-use

Unistik Touch - 00384701462016

Unistik Touch contact activated safety lancet - 16G x 2.0mm, highest flow.
OWEN MUMFORD LIMITED
AT 1462
In Commercial Distribution

  • 00384701462030 ()
  • 00384701462016 ()
  • 00384701462009 ()

  • Needle Gauge: 16 Gauge


  • Manual blood lancing device, single-use

Unistik Touch - 00384701444012

Unistik Touch - Contact Activated Safety Lancet - 28G x 1.8mm - 200 count - sterile single use safety lancet
OWEN MUMFORD LIMITED
AT 1444
In Commercial Distribution

  • 00384701444036 ()
  • 00384701444012 ()
  • 00384701442001 ()

  • Needle Gauge: 28 Gauge
  • Depth: 1.8 Millimeter


  • Manual blood lancing device, single-use

Unistik Touch - 00384701442018

Unistik Touch - Contact Activated Safety Lancet - 28G x 1.8mm - sterile single use safety lancet
OWEN MUMFORD LIMITED
AT 1442
In Commercial Distribution

  • 00384701442032 ()
  • 00384701442018 ()
  • 00384701442001 ()

  • Needle Gauge: 28 Gauge
  • Depth: 1.8 Millimeter


  • Manual blood lancing device, single-use

Unistik Touch - 00384701424014

Unistik Touch - Contact Activated Safety Lancet - 30G x 1.5mm - 200 count - sterile single use safety lancet
OWEN MUMFORD LIMITED
AT 1424
In Commercial Distribution

  • 00384701424038 ()
  • 00384701424014 ()
  • 00384701422003 ()

  • Needle Gauge: 30 Gauge
  • Depth: 1.5 Millimeter


  • Manual blood lancing device, single-use

Unistik Touch - 00384701422010

Unistik Touch - Contact Activated Safety Lancet - 30G x 1.5mm - sterile single use safety lancet
OWEN MUMFORD LIMITED
AT 1422
In Commercial Distribution

  • 00384701422034 ()
  • 00384701422010 ()
  • 00384701422003 ()

  • Needle Gauge: 30 Gauge
  • Depth: 1.5 Millimeter


  • Manual blood lancing device, single-use

Unistik Touch - 00384701414015

Unistik Touch - Contact Activated Safety Lancet - 21G x 2.0mm - 200 count - sterile, single use safety lancet.
OWEN MUMFORD LIMITED
AT 1414
In Commercial Distribution

  • 00384701414039 ()
  • 00384701414015 ()
  • 00384701412004 ()

  • Needle Gauge: 21 Gauge
  • Depth: 2.0 Millimeter


  • Manual blood lancing device, single-use

Unistik Touch - 00384701412011

Unistik Touch - Contact Activated Safety Lancet - 21G x 2.0mm - sterile, single use safety lancet
OWEN MUMFORD LIMITED
AT 1412
In Commercial Distribution

  • 00384701412035 ()
  • 00384701412011 ()
  • 00384701412004 ()

  • Needle Gauge: 21 Gauge
  • Depth: 2.0 Millimeter


  • Manual blood lancing device, single-use

Unistik Touch - 00384701404016

Unistik Touch - Contact Activated Safety Lancet - 23G x 2.0mm - 200 count - sterile, single use safety lancet
OWEN MUMFORD LIMITED
AT 1404
In Commercial Distribution

  • 00384701404030 ()
  • 00384701404016 ()
  • 00384701402005 ()

  • Needle Gauge: 23 Gauge
  • Depth: 2.0 Millimeter


  • Manual blood lancing device, single-use

Unistik Touch - 00384701402012

Unistik Touch contact activated safety lancets - 23G x 2.0mm - medium flow
OWEN MUMFORD LIMITED
AT 1402
In Commercial Distribution

  • 00384701402036 ()
  • 00384701402012 ()
  • 00384701402005 ()

  • Needle Gauge: 23 Gauge
  • Depth: 2.0 Millimeter


  • Manual blood lancing device, single-use

Unistik TinyTouch - 00384701267017

Unsitik TinyTouch Low Flow 18G
OWEN MUMFORD USA INCORPORATED
AT 1267
In Commercial Distribution

  • 00384701267024 ()
  • 00384701267017 ()
  • 00384701267031 ()
  • 00384701267000 ()

  • Needle Gauge: 18 Gauge
  • Depth: 1.8 Millimeter


  • Manual blood lancing device, single-use

Unistik TinyTouch - 00384701260018

Unistik TinyTouch Full Term individually packaged in a carton, 1.0mm x 2.50mm
OWEN MUMFORD USA INCORPORATED
AT 1260
In Commercial Distribution

  • 00384701260032 ()
  • 00384701260018 ()
  • 00384701250002 ()


  • Manual blood lancing device, single-use
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