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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PENTOBARBITAL LEVEL 1
UTAK LABORATORIES, INC.
PENTO 1 V2 S BH
In Commercial Distribution

  • B800PENTO1V2SBH5 ()
  • B800PENTO1V2SBH0 ()

  • Total Volume: 5 Milliliter
PENTO 1 V2 S BH

  • Multiple-type clinical chemistry analyte profile IVD, control
OPIATES URINE QC
UTAK LABORATORIES, INC.
OPIA 1 V2 U WHM
In Commercial Distribution

  • B800OPIA1V2UWHM5 ()
  • B800OPIA1V2UWHM0 ()

  • Total Volume: 5 Milliliter
OPIA 1 V2 U WHM

  • Multiple-type clinical chemistry analyte profile IVD, control
NIDA LOW
UTAK LABORATORIES, INC.
NIDA LOW V2 F CRL
In Commercial Distribution

  • B800NIDALOWV2FCRL5 ()
  • B800NIDALOWV2FCRL0 ()

  • Total Volume: 120 Milliliter
NIDA LOW V2 F CRL

  • Multiple drugs of abuse IVD, control
NIDA CUTOFF
UTAK LABORATORIES, INC.
NIDA CUT V2 F CRL
In Commercial Distribution

  • B800NIDACUTV2FCRL5 ()
  • B800NIDACUTV2FCRL0 ()

  • Total Volume: 120 Milliliter
NIDA CUT V2 F CRL

  • Multiple drugs of abuse IVD, control
MD LABS 43 DRUGS LOW
UTAK LABORATORIES, INC.
MD LABS 43 V2 LOW
In Commercial Distribution

  • B800MDLABS43V2LOW5 ()
  • B800MDLABS43V2LOW0 ()

  • Total Volume: 1 Milliliter
MD LABS 43 V2 LOW

  • Multiple-type clinical chemistry analyte profile IVD, control
MD LABS 43 DRUGS HIGH
UTAK LABORATORIES, INC.
MD LABS 43 V2 HIGH
In Commercial Distribution

  • B800MDLABS43V2HIGH0 ()

  • Total Volume: 1 Milliliter
MD LABS 43 V2 HIGH

  • Multiple-type clinical chemistry analyte profile IVD, control
FENTANYL PLUS LEVEL 4
UTAK LABORATORIES, INC.
FENT+ 4 V2 U NJSP
In Commercial Distribution

  • B800FENT4V2UNJSP5 ()
  • B800FENT4V2UNJSP0 ()

  • Total Volume: 5 Microliter
FENT+ 4 V2 U NJSP

  • Multiple-type clinical chemistry analyte profile IVD, control
FENTANYL PLUS LEVEL 3
UTAK LABORATORIES, INC.
FENT+ 3 V2 U NJSP
In Commercial Distribution

  • B800FENT3V2UNJSP5 ()
  • B800FENT3V2UNJSP0 ()

  • Total Volume: 5 Microliter
FENT+ 3 V2 U NJSP

  • Multiple-type clinical chemistry analyte profile IVD, control
FENTANYL PLUS LEVEL 2
UTAK LABORATORIES, INC.
FENT+ 2 V2 U NJSP
In Commercial Distribution

  • B800FENT2V2UNJSP5 ()
  • B800FENT2V2UNJSP0 ()

  • Total Volume: 5 Milliliter
FENT+ 2 V2 U NJSP

  • Multiple-type clinical chemistry analyte profile IVD, control
FENTANYL PLUS LEVEL 1
UTAK LABORATORIES, INC.
FENT+ 1 V2 U NJSP
In Commercial Distribution

  • B800FENT1V2UNJSP5 ()
  • B800FENT1V2UNJSP0 ()

  • Total Volume: 5 Milliliter
FENT+ 1 V2 U NJSP

  • Multiple-type clinical chemistry analyte profile IVD, control
ETHANOL 50 MG/DL
UTAK LABORATORIES, INC.
ETH 50 V2 U UMMC
In Commercial Distribution

  • B800ETH50V2UUMMC5 ()
  • B800ETH50V2UUMMC0 ()

  • Total Volume: 5 Milliliter
ETH 50 V2 U UMMC

  • Multiple-type clinical chemistry analyte profile IVD, control
AXIS VOL QC #4
UTAK LABORATORIES, INC.
ETH 350 V2 W AIT
In Commercial Distribution

  • B800ETH350V2WAIT5 ()
  • B800ETH350V2WAIT0 ()

  • Total Volume: 5 Milliliter
ETH 350 V2 W AIT

  • Multiple-type clinical chemistry analyte profile IVD, control
ETHANOL 20 MG/DL
UTAK LABORATORIES, INC.
ETH 20 V2 U UMMC
In Commercial Distribution

  • B800ETH20V2UUMMC5 ()
  • B800ETH20V2UUMMC0 ()

  • Total Volume: 5 Milliliter
ETH 20 V2 U UMMC

  • Multiple-type clinical chemistry analyte profile IVD, control
ETGCALV2MLB
UTAK LABORATORIES, INC.
ETG CAL V2 M LB
In Commercial Distribution

  • B800ETGCALV2MLB5 ()
  • B800ETGCALV2MLB0 ()

  • Total Volume: 0.5 Milliliter
ETG CAL V2 M LB

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE 3
UTAK LABORATORIES, INC.
DA WB 3 V2 OCME
In Commercial Distribution

  • B800DAWB3V2OCME5 ()
  • B800DAWB3V2OCME0 ()

  • Total Volume: 10 Milliliter
DA WB 3 V2 OCME

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE
UTAK LABORATORIES, INC.
DA WB 2PT V2 SDHL
In Commercial Distribution

  • B800DAWB2PTV2SDHL5 ()
  • B800DAWB2PTV2SDHL0 ()

  • Total Volume: 2 Milliliter
DA WB 2PT V2 SDHL

  • Multiple-type clinical chemistry analyte profile IVD, control
No Description
IMPLANET
Madison BL Threaded Rod V2
In Commercial Distribution

  • 03607505404547 ()
540454

  • Orthopaedic surgical procedure kit, non-medicated, reusable
A mains electricity (AC-powered) device specifically designed to be used when placed in a bed or chair. It may be fixed into appropriate beds or chairs providing other functions. It will provide a massaging therapeutic effect to the person occupying the bed or chair typically to ease aches and pains in the body. It may be used in an institution, but is typically designed for home use.
Human Touch, LLC
HT GRAVIS MAHOGANY BASE V2
In Commercial Distribution

  • 00045915829674 ()
100-GRAVIS-005

  • Bed/chair electric massager
A mains electricity (AC-powered) device specifically designed to be used when placed in a bed or chair. It may be fixed into appropriate beds or chairs providing other functions. It will provide a massaging therapeutic effect to the person occupying the bed or chair typically to ease aches and pains in the body. It may be used in an institution, but is typically designed for home use.
Human Touch, LLC
HT GRAVIS BEECH BASE V2
In Commercial Distribution

  • 00045915829667 ()
100-GRAVIS-004

  • Bed/chair electric massager
A mains electricity (AC-powered) device specifically designed to be used when placed in a bed or chair. It may be fixed into appropriate beds or chairs providing other functions. It will provide a massaging therapeutic effect to the person occupying the bed or chair typically to ease aches and pains in the body. It may be used in an institution, but is typically designed for home use.
Human Touch, LLC
HT GRAVIS BLACK BASE V2
In Commercial Distribution

  • 00045915829506 ()
100-GRAVIS-003

  • Bed/chair electric massager
No Description
ASHLAND SPECIALTY INGREDIENTS G.P.
EBT4 Reflexion Film V2 @20SH
In Commercial Distribution

  • 00810106410852 ()
989194

  • Medical x-ray film, non-screen
Gafchromic Films
ASHLAND SPECIALTY INGREDIENTS G.P.
EBT3 Reflexion Film V2 @20SH
In Commercial Distribution

  • 00810106410395 ()
982341

  • Medical x-ray film, non-screen
Sterile needle guide with (14 x 61cm) flat-folded CIV-Flex™ cover for use with Siemens 4V2, V4, V2, L5, L7, C3, C366, C5, C544, 8L5, 6L3 and 5C2 transducers
CIVCO MEDICAL INSTRUMENTS CO., INC.
612-068
In Commercial Distribution

  • 00841436104838 ()
  • 10841436104835 ()

  • Width: 1.8 Inch
  • Length: 4.8 Inch
612-068

  • Needle guide, single-use
The Revian 2M USB to Magnetic Cable & Insert v2 Replacement Kit is a kit that may be shipped to users of the REVIAN Red device (Catalog # 10001) who have lost or misplaced their Magnetic Micro-USB Connector or Magnetic Cable originally supplied with the REVIAN Red Device.
Revian, Inc.
10000-12722
In Commercial Distribution

  • 00850003374130 ()
12722

  • Hair growth laser device
No Description
Roche Molecular Systems, Inc.
09048634190
In Commercial Distribution

  • 00875197006285 ()
09048634190

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Warmed Gutta Percha Obturation System
Meta Biomed Co., Ltd.
9050
Not in Commercial Distribution

  • 08806387890508 ()


  • Endodontic obturation system
No Description
MICROSURGICAL TECHNOLOGY, INC.
Ti-98432
In Commercial Distribution

  • 00844685004096 ()
Ti-98432

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
No Description
MICROSURGICAL TECHNOLOGY, INC.
Ti-98431
In Commercial Distribution

  • 00844685004089 ()
Ti-98431

  • Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
No Description
Natus Medical Denmark ApS
1085, FACE PAD ASSEMBLY KIT V2
In Commercial Distribution

  • 05713315008467 ()
  • 05713315008504 ()
  • 05713315008498 ()
8-35-39300

  • Electronystagmograph
DRUGS OF ABUSE POSITIVE
UTAK LABORATORIES, INC.
DA POS V2 WB F KBI
In Commercial Distribution

  • B800DAPOSV2WBFKBI5 ()
  • B800DAPOSV2WBFKBI0 ()

  • Total Volume: 3 Milliliter
DA POS V2 WB F KBI

  • Multiple drugs of abuse IVD, control
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