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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AIRFIT F10 FRAME SYSTEM MEDIUM
RESMED PTY LTD
63162
In Commercial Distribution

  • 00619498631629 ()
63162

  • CPAP/BPAP face mask, reusable
AIRFIT F10 FRAME SYSTEM SMALL
RESMED PTY LTD
63161
In Commercial Distribution

  • 00619498631612 ()
63161

  • CPAP/BPAP face mask, reusable
AIRFIT F 10 FRAME SYSTEM EXTRA SMALL
RESMED PTY LTD
63160
In Commercial Distribution

  • 00619498631605 ()
63160

  • CPAP/BPAP face mask, reusable
AIRFIT P10 FRAME
RESMED PTY LTD
62938
In Commercial Distribution

  • 00619498629381 ()
62938

  • CPAP/BPAP nasal mask, reusable
AIRFIT P10 FOR HER ADJUSTABLE HG
RESMED PTY LTD
62936
In Commercial Distribution

  • 00619498629367 ()
62936

  • CPAP/BPAP nasal mask, reusable
AIRFIT P10 ADJUSTABLE HEADGEAR
RESMED PTY LTD
62935
In Commercial Distribution

  • 00619498629350 ()
62935

  • CPAP/BPAP nasal mask, reusable
AIRFIT P 10 PILLOW -LGE
RESMED PTY LTD
62933
In Commercial Distribution

  • 00619498629336 ()
62933

  • CPAP/BPAP nasal mask, reusable
AIRFIT P 10 PILLOW -MED
RESMED PTY LTD
62932
In Commercial Distribution

  • 00619498629329 ()
62932

  • CPAP/BPAP nasal mask, reusable
AIRFIT P 10 PILLOW-SML
RESMED PTY LTD
62931
In Commercial Distribution

  • 00619498629312 ()
62931

  • CPAP/BPAP nasal mask, reusable
AIRFIT P 10 PILLOW- XSML
RESMED PTY LTD
62930
In Commercial Distribution

  • 00619498629305 ()
62930

  • CPAP/BPAP nasal mask, reusable
AIRFIT P10 MASK SYS FOR HER SLM
RESMED PTY LTD
62927
In Commercial Distribution

  • 00619498629275 ()
  • 00619498002306 ()
62927

  • CPAP/BPAP nasal mask, reusable
AIRFIT P10 MASK SYSTEM SLM
RESMED PTY LTD
62925
In Commercial Distribution

  • 00619498629251 ()
  • 00619498002306 ()
62925

  • CPAP/BPAP nasal mask, reusable
AIRFIT P 10 FRAME SYS -LARGE
RESMED PTY LTD
62923
In Commercial Distribution

  • 00619498629237 ()
62923

  • CPAP/BPAP nasal mask, reusable
AIRFIT P 10 FRAME SYS -MEDIUM
RESMED PTY LTD
62922
In Commercial Distribution

  • 00619498629220 ()
62922

  • CPAP/BPAP nasal mask, reusable
AIRFIT P 10 FRAME SYS -SMALL
RESMED PTY LTD
62921
In Commercial Distribution

  • 00619498629213 ()
62921

  • CPAP/BPAP nasal mask, reusable
AIRFIT P 10 FRAME SYS -XSML
RESMED PTY LTD
62920
In Commercial Distribution

  • 00619498629206 ()
62920

  • CPAP/BPAP nasal mask, reusable
AIRFIT P 10 FOR HER NASAL MASK
RESMED PTY LTD
62910
In Commercial Distribution

  • 00619498629107 ()
62910

  • CPAP/BPAP nasal mask, reusable
AIRFIT P 10 NASAL MASK
RESMED PTY LTD
62900
In Commercial Distribution

  • 00619498629008 ()
62900

  • CPAP/BPAP nasal mask, reusable
10" Cement Rongeur
SYMMETRY MEDICAL INC.
15-002-000-1500
In Commercial Distribution

  • 00847538006124 ()
2011-03-044

  • Surgical soft-tissue manipulation forceps, alligator, reusable
Sterile disposables microkeratome blade, for use on the Hansatome Microkeratome
MED LOGICS INC
ML7070 (+10)
In Commercial Distribution

  • 10850724001596 ()
  • 00850724001599 ()
ML7070 (+10)

  • Keratome blade, single-use
Sterile disposables microkeratome blade, for use on the Hansatome Microkeratome
MED LOGICS INC
ML7070 (-10)
In Commercial Distribution

  • 10850724001572 ()
  • 00850724001575 ()
ML7070 (-10)

  • Keratome blade, single-use
Sterile disposable microkeratome blade, for use on the MED-LOGICS, Inc. ML7061 Metal Head
MED LOGICS INC
ML7061 (-10)
In Commercial Distribution

  • 10850724001367 ()
  • 00850724001360 ()
ML7061 (-10)

  • Keratome blade, single-use
Sterile disposable microkeratome blade, for use on the Moria® M2 Microkeratome, Sample
MED LOGICS INC
ML7050 (+10)
In Commercial Distribution

  • 00850724001353 ()
  • 10850724001350 ()
ML7050 (+10)

  • Keratome blade, single-use
Sterile disposable microkeratome blade, for use on the MED-LOGICS ML7™ Microkeratome, Sample
MED LOGICS INC
ML7100 (+10)
In Commercial Distribution

  • 00850724001346 ()
  • 10850724001343 ()
ML7100 (+10)

  • Keratome blade, single-use
Sterile disposable microkeratome blade, for use on the Moria® C-B Microkeratome, Sample
MED LOGICS INC
ML7020 (-10)
In Commercial Distribution

  • 00850724001315 ()
  • 10850724001312 ()
ML7020 (-10)

  • Keratome blade, single-use
Sterile disposable microkeratome blade, for use on the Nidek® MK-2000 Keratome System, Sample
MED LOGICS INC
ML7030 (+10)
In Commercial Distribution

  • 00850724001230 ()
  • 10850724001237 ()
ML7030 (+10)

  • Keratome blade, single-use
Sterile disposable microkeratome blade, for use on the MED-LOGICS, Inc. ML7061 Metal Head
MED LOGICS INC
ML7061 (+10)
In Commercial Distribution

  • 10850724001176 ()
  • 00850724001179 ()
ML7061 (+10)

  • Keratome blade, single-use
Sterile disposable microkeratome blade, for use on the Moria® M2 Microkeratome, Sample
MED LOGICS INC
ML7050 (-10)
In Commercial Distribution

  • 00850724001155 ()
  • 10850724001152 ()
ML7050 (-10)

  • Keratome blade, single-use
Sterile disposable microkeratome blade, for use on the Moria® C-B Microkeratome, Sample
MED LOGICS INC
ML7020 (+10)
In Commercial Distribution

  • 00850724001124 ()
  • 10850724001121 ()
ML7020 (+10)

  • Keratome blade, single-use
Sterile disposable microkeratome blade, for use on the MED-LOGICS ML7™ Microkeratome, Sample
MED LOGICS INC
ML7100 (-10)
In Commercial Distribution

  • 00850724001094 ()
  • 10850724001091 ()
ML7100 (-10)

  • Keratome blade, single-use
Sterile disposable microkeratome blade, for use on the Nidek® MK-2000 Keratome System, Sample
MED LOGICS INC
ML7030 (-10)
In Commercial Distribution

  • 00850724001032 ()
  • 10850724001039 ()
ML7030 (-10)

  • Keratome blade, single-use
NEWLIFE INTENSITY 10 OXYGEN CONCENTRATOR, 10LPM, O2 MONITOR, DUAL
CAIRE INC.
AS099-4
In Commercial Distribution

  • M766AS09940 ()


  • Stationary oxygen concentrator
NEWLIFE INTENSITY 10 OXYGEN CONCENTRATOR, 10LPM, REFURBISHED
CAIRE INC.
AS099-1U
In Commercial Distribution

  • M766AS0991U0 ()


  • Stationary oxygen concentrator
NEWLIFE INTENSITY 10 OXYGEN CONCENTRATOR, 10LPM, O2 MONITOR, REFURBISHED
CAIRE INC.
AS099-101U
In Commercial Distribution

  • M766AS099101U0 ()


  • Stationary oxygen concentrator
NEWLIFE INTENSITY 10 OXYGEN CONCENTRATOR, 10LPM, SINGLE, REFURBISHED
CAIRE INC.
AS099-100U
In Commercial Distribution

  • M766AS099100U0 ()


  • Stationary oxygen concentrator
NEWLIFE INTENSITY 10 OXYGEN CONCENTRATOR, 10LPM, O2 MONITOR, DUAL, REFURBISHED
CAIRE INC.
AS099-4U
In Commercial Distribution

  • M766AS0994U0 ()


  • Stationary oxygen concentrator
NEWLIFE INTENSITY 10 OXYGEN CONCENTRATOR, 10LPM, 02 MONITOR
CAIRE INC.
AS099-101
In Commercial Distribution

  • M766AS0991010 ()


  • Stationary oxygen concentrator
NEWLIFE INTENSITY 10 OXYGEN CONCENTRATOR, 10LPM, SINGLE
CAIRE INC.
AS099-100
In Commercial Distribution

  • M766AS0991000 ()


  • Stationary oxygen concentrator
NEWLIFE INTENSITY 10 OXYGEN CONCENTRATOR, 10LPM, DUAL
CAIRE INC.
AS099-1
In Commercial Distribution

  • M766AS09910 ()


  • Stationary oxygen concentrator
Lateral flow immunoassay for the detection of drugs of abuse in urine: Cocaine (COC), Amphetamine (AMP), Methamphetamine (mAMP), Marijuana (THC), Methadone (MTD), Opiates (OPI), Phencyclidine (PCP), Barbiturates (BAR), Benzodiazpines (BZO), Ecstasy (MDMA).
GERMAINE LABORATORIES, INC
40125
In Commercial Distribution

  • 00695684401252 ()
  • 00695684401251 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Tricyclic antidepressant IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Benzodiazepine group IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
  • Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
  • Methamphetamine-specific IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, kit, rapid ICT, clinical
Urine Reagent Strips (URS) for Urinalysis are firm plastic strips to which several different reagent areas are affixed
Immunostics Company, Inc
IDU-10
In Commercial Distribution

  • 20722355002204 ()
  • 10722355002221 ()
  • 80722355002220 ()


  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
No Description
Sonova AG
10.0
In Commercial Distribution

  • 07613389716115 ()
088-0125-100

  • Audiometric/hearing device software
No Description
ELECTRO-CAP INTERNATIONAL INC
I1-2
In Commercial Distribution

  • 00811478012514 ()
I1-2

  • Analytical scalp lead
V-Trak
MICROVENTION INC.
7110-1243
In Commercial Distribution

  • 00811425029732 ()

  • 12 mm x 43 cm
7110-1243

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
7110-1139
In Commercial Distribution

  • 00811425029725 ()

  • 11 mm x 39 cm
7110-1139

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
7110-1036
In Commercial Distribution

  • 00811425029718 ()

  • 10 mm x 36 cm
7110-1036

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
7110-0931
In Commercial Distribution

  • 00811425029701 ()

  • 9 mm x 31 cm
7110-0931

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
7110-0833
In Commercial Distribution

  • 00811425029695 ()

  • 8 mm x 33 cm
7110-0833

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
7110-0826
In Commercial Distribution

  • 00811425029688 ()

  • 8 mm x 26 cm
7110-0826

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
7110-0817
In Commercial Distribution

  • 00811425029671 ()

  • 8 mm x 17 cm
7110-0817

  • Neurovascular embolization coil
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