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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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No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-59-0105
In Commercial Distribution

  • 09348215134693 ()


  • Coated hip femur prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-59-0005
In Commercial Distribution

  • 09348215134563 ()


  • Coated hip femur prosthesis, modular
No Description
IT-V Medizintechnik GmbH
P10107-642
In Commercial Distribution

  • 09120074396425 ()


  • Radiological whole-body positioner
No Description
IT-V Medizintechnik GmbH
P10107-483
In Commercial Distribution

  • 09120074394834 ()


  • Radiological whole-body positioner
No Description
Orasure Technologies, Inc.
1150EB
In Commercial Distribution

  • 00608337000689 ()


  • Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA)
No Description
Orasure Technologies, Inc.
1122SB
In Commercial Distribution

  • 00608337000412 ()


  • Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA),
No Description
Orasure Technologies, Inc.
1142IB
In Commercial Distribution

  • 00608337000320 ()


  • Methadone IVD, kit, enzyme immunoassay (EIA)
No Description
Brainlab AG
43458
In Commercial Distribution

  • 04056481145484 ()


  • Indexed-immobilization patient positioning system
MultiStim, (TR) 3" x 5", Cloth, (2/pk)
COMPASS HEALTH BRANDS CORP.
400-8522
In Commercial Distribution

  • 30092237622255 ()
  • 00092237622254 ()
  • 01092237622253 ()
  • 80092237622250 ()


  • Transcutaneous electrical stimulation electrode, single-use
4mm AdvanSync Spacer, Pk/5
ALLESEE AOA-PRO
MATER207
In Commercial Distribution

  • 10889989083252 ()
  • 00889989083255 ()


  • Orthodontic clasp, metal, custom-made
COTININE PLUS 5 NG/ML
UTAK LABORATORIES, INC.
COT+ 5 S WDL
In Commercial Distribution

  • B800COT5SWDL5 ()
  • B800COT5SWDL0 ()

  • Total Volume: 15 Milliliter
COT+ 5 S WDL

  • Multiple-type clinical chemistry analyte profile IVD, control
BUSULFAN CALIBRATOR LEVEL 5 V2
UTAK LABORATORIES, INC.
BUS CAL 5 V2 DP F MDACC
In Commercial Distribution

  • B800BUSCAL5V2DPFMDACC5 ()
  • B800BUSCAL5V2DPFMDACC0 ()

  • Total Volume: 1.5 Milliliter
BUS CAL 5 V2 DP F MDACC

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE LEVEL 5
UTAK LABORATORIES, INC.
DAU CAL 5 V3 F NHI
In Commercial Distribution

  • B800DAUCAL5V3FNHI5 ()
  • B800DAUCAL5V3FNHI0 ()

  • Total Volume: 1 Milliliter
DAU CAL 5 V3 F NHI

  • Multiple drugs of abuse IVD, control
DRUGS OF ABUSE CALIBRATOR 5
UTAK LABORATORIES, INC.
DAU CAL 5 U F NPIL
In Commercial Distribution

  • B800DAUCAL5UFNPIL5 ()
  • B800DAUCAL5UFNPIL0 ()

  • Total Volume: 2 Milliliter
DAU CAL 5 U F NPIL

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE LEVEL 5
UTAK LABORATORIES, INC.
DAU 5 F LE
In Commercial Distribution

  • B800DAU5FLE5 ()
  • B800DAU5FLE0 ()

  • Total Volume: 12 Milliliter
DAU 5 F LE

  • Multiple drugs of abuse IVD, control
VOLATILES PLUS 5 MG/DL
UTAK LABORATORIES, INC.
VOL+ 5 MFCL
In Commercial Distribution

  • B800VOL5MFCL5 ()
  • B800VOL5MFCL0 ()

  • Total Volume: 3 Milliliter
VOL+ 5 MFCL

  • Multiple-type clinical chemistry analyte profile IVD, control
ISAVUCONAZOLE PLUS CALIBRATOR 5 V2
UTAK LABORATORIES, INC.
ISA+ CAL 5 V2 S F UCSF
In Commercial Distribution

  • B800ISACAL5V2SFUCSF5 ()
  • B800ISACAL5V2SFUCSF0 ()

  • Total Volume: 1 Milliliter
ISA+ CAL 5 V2 S F UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control
ETG PLUS CALIBRATOR LEVEL 5
UTAK LABORATORIES, INC.
ETG+ CAL 5 V2 U F UCSF
In Commercial Distribution

  • B800ETGCAL5V2UFUCSF5 ()
  • B800ETGCAL5V2UFUCSF0 ()

  • Total Volume: 1 Milliliter
ETG+ CAL 5 V2 U F UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control
SERUM DRUG SCREEN LEVEL 5
UTAK LABORATORIES, INC.
DS 5 S ID
In Commercial Distribution

  • B800DS5SID5 ()
  • B800DS5SID0 ()

  • Total Volume: 3 Milliliter
DS 5 S ID

  • Benzodiazepine group IVD, control
No Description
BISCO INC.
X-81268P
Not in Commercial Distribution

  • D757X81268P1 ()

  • sixe text
X-81268P

  • Dental material injection cannula, single-use
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