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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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
V-Trak
MICROVENTION INC.
7110-0728
In Commercial Distribution

  • 00811425029664 ()

  • 7 mm x 28 cm
7110-0728

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
7110-0723
In Commercial Distribution

  • 00811425029657 ()

  • 7 mm x 23 cm
7110-0723

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
7110-0715
In Commercial Distribution

  • 00811425029640 ()

  • 7 mm x 15 cm
7110-0715

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
7110-0623
In Commercial Distribution

  • 00811425029633 ()

  • 6 mm x 23 cm
7110-0623

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
7110-0619
In Commercial Distribution

  • 00811425029626 ()

  • 6 mm x 19 cm
7110-0619

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
7110-0612
In Commercial Distribution

  • 00811425029619 ()

  • 6 mm x 12 cm
7110-0612

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
7110-0519
In Commercial Distribution

  • 00811425029602 ()

  • 5 mm x 19 cm
7110-0519

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
7110-0515
In Commercial Distribution

  • 00811425029596 ()

  • 5 mm x 15 cm
7110-0515

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
7110-0510
In Commercial Distribution

  • 00811425029589 ()

  • 5 mm x 10 cm
7110-0510

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
7110-0412
In Commercial Distribution

  • 00811425029572 ()

  • 4 mm x 12 cm
7110-0412

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
7110-0408
In Commercial Distribution

  • 00811425029565 ()

  • 4 mm x 8 cm
7110-0408

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
7110-0405
In Commercial Distribution

  • 00811425029558 ()

  • 4 mm x 5 cm
7110-0405

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
7110-0306
In Commercial Distribution

  • 00811425029541 ()

  • 3 mm x 6 cm
7110-0306

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
7110-0254
In Commercial Distribution

  • 00811425029534 ()

  • 2.5 mm x 4 cm
7110-0254

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
7110-0202
In Commercial Distribution

  • 00811425029527 ()

  • 2 mm x 2 cm
7110-0202

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
101036HFRM-V-A
In Commercial Distribution

  • 00811425027219 ()

  • 10 mm x 36 cm
101036HFRM-V

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
100931HFRM-V-A
In Commercial Distribution

  • 00811425027202 ()

  • 9 mm x 31 cm
100931HFRM-V

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
100833HFRM-V-A
In Commercial Distribution

  • 00811425027196 ()

  • 8 mm x 33 cm
100833HFRM-V

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
100817HFRM-V-A
In Commercial Distribution

  • 00811425027172 ()

  • 8 mm x 17 cm
100817HFRM-V

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
100728HFRM-V-A
In Commercial Distribution

  • 00811425027165 ()

  • 7 mm x 28 cm
100728HFRM-V

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
100715HFRM-V-A
In Commercial Distribution

  • 00811425027141 ()

  • 7 mm x 15 cm
100715HFRM-V

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
100619HFRM-V-A
In Commercial Distribution

  • 00811425027127 ()

  • 6 mm x 19 cm
100619HFRM-V

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
100612HFRM-V-A
In Commercial Distribution

  • 00811425027110 ()

  • 6 mm x 12 cm
100612HFRM-V

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
100515HFRM-V-A
In Commercial Distribution

  • 00811425027097 ()

  • 5 mm x 15 cm
100515HFRM-V

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
100510HFRM-V-A
In Commercial Distribution

  • 00811425027080 ()

  • 5 mm x 10 cm
100510HFRM-V

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
100408HFRM-V-A
In Commercial Distribution

  • 00811425027066 ()

  • 4 mm x 8 cm
100408HFRM-V

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
100405HFRM-V-A
In Commercial Distribution

  • 00811425027059 ()

  • 4 mm x 5 cm
100405HFRM-V

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
100306HFRM-V-A
In Commercial Distribution

  • 00811425027042 ()

  • 3 mm x 6 cm
100306HFRM-V

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
100254HFRM-V-A
In Commercial Distribution

  • 00811425027035 ()

  • 2.5 mm x 4 cm
100254HFRM-V

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
100202HFRM-V-A
In Commercial Distribution

  • 00811425027028 ()

  • 2 mm x 2 cm
100202HFRM-V

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
8210-1245
In Commercial Distribution

  • 00811425028377 ()

  • 12 mm x 45 cm
8210-1245

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
8210-1141
In Commercial Distribution

  • 00811425028360 ()

  • 11 mm x 41 cm
8210-1141

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
8210-1036
In Commercial Distribution

  • 00811425028353 ()

  • 10 mm x 36 cm
8210-1036

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
8210-0933
In Commercial Distribution

  • 00811425028346 ()

  • 9 mm x 33 cm
8210-0933

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
8210-0837
In Commercial Distribution

  • 00811425028339 ()

  • 8 mm x 37 cm
8210-0837

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
8210-0825
In Commercial Distribution

  • 00811425028322 ()

  • 8 mm x 25 cm
8210-0825

  • Neurovascular embolization coil
V-Trak
MICROVENTION INC.
8210-0731
In Commercial Distribution

  • 00811425028315 ()

  • 7 mm x 31 cm
8210-0731

  • Neurovascular embolization coil
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