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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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DrugSmart Cup 9 - 00850019007787

DrugSmart Cup 9 CLIA-Waived, THC/COC/OPI2K/OXY/AMP/MET/MTD/BZO/BUP, 25tests/kit
CHEMTRON BIOTECH INC
C-60960D
In Commercial Distribution

  • 00850019007787 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

AIMSCREEN MULTIDRUG 9 - 00695684409258

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).
GERMAINE LABORATORIES, INC
40925
In Commercial Distribution

  • 00695684409258 ()
  • 00695684409251 ()


  • Cannabinoid/cannabinoid metabolite IVD, kit, rapid ICT, clinical
  • Barbiturate IVD, kit, rapid ICT, clinical
  • Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
  • Methadone IVD, kit, rapid ICT, clinical
  • Amphetamine-specific IVD, kit, rapid ICT, clinical
  • Benzodiazepine group 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

HEADREST, 9" DONUT - 00842430105876

No Description
MIZUHO ORTHOPEDIC SYSTEMS, INC.
1921
In Commercial Distribution

  • 00842430105876 ()
  • 00842430109041 ()
1921

  • Freestanding headrest, single-use

Phonak Target 9 - 07613389675313

No Description
Sonova AG
9.0 USB Stick
In Commercial Distribution

  • 07613389675313 ()
058-0321

  • Audiometric/hearing device software

DrugSmart Cup 9 - 00812203030605

DrugSmart Cup 9 CLIA-Waived, AMP/COC/OPI2K/MET/PCP/BAR/BZO/PPX/MTD, 25tests/kit
CHEMTRON BIOTECH INC
C-60930D
In Commercial Distribution

  • 00812203030605 ()


  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical

VITA VM 9 - J017BV9OCK3M2V10

VITA VM 9 ONE COLOR KIT 3M2
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
BV9OCK3M2V1
In Commercial Distribution

  • J017BV9OCK3M2V10 ()


  • Dental appliance fabrication material, ceramic

VITA VM 9 - J017BV9OCK2M2V40

VITAVM®9 ONE COLOR KIT 2M2
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
BV9OCK2M2V4
In Commercial Distribution

  • J017BV9OCK2M2V40 ()


  • Dental appliance fabrication material, ceramic

VITA VM 9 - J017BV9MKV10

VITAVM®9 MARGIN KIT
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
BV9MKV1
In Commercial Distribution

  • J017BV9MKV10 ()


  • Dental appliance fabrication material, ceramic

VITA VM 9 - J017BV9BUK12V10

VITAVM®9 BUILD UP KIT
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
BV9BUK12V1
In Commercial Distribution

  • J017BV9BUK12V10 ()


  • Dental appliance fabrication material, ceramic

VITA VM 9 - J017BV9BUK12C0

VITA VM 9 BUILD UP KIT classical
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
BV9BUK12C
In Commercial Distribution

  • J017BV9BUK12C0 ()


  • Dental appliance fabrication material, ceramic
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