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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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IMPLANT STYLE +5 RING-LOC - 00880304299849

No Description
Biomet Orthopedics, LLC
31-103902
In Commercial Distribution

  • 00880304299849 ()
31-103902

  • Acetabulum prosthesis trial, prefabricated, reusable

ALI-HAND XLG 5/PK - 00733657239393

No Description
ALIMED, INC.
931036
In Commercial Distribution

  • 00733657239393 ()
  • 00733657299441 ()
2970013247

  • Hand/finger splint, reusable

ALI-HAND STD 5/PK - 00733657239386

No Description
ALIMED, INC.
931035
In Commercial Distribution

  • 00733657239386 ()
  • 00733657299434 ()
2970013246

  • Hand/finger splint, reusable

Tg II CalCheck 5 - 07613336180877

No Description
Roche Diagnostics GmbH
05918081190
In Commercial Distribution

  • 07613336180877 ()
05918081190

  • Thyroglobulin IVD, control

FlexiBuff Mini 5/8 - D7734026581

No Description
COSMEDENT, INC.
402658
In Commercial Distribution

  • D7734026581 ()


  • Dental abrasive disk, single-use

BUSULFAN CALIBRATOR LEVEL 5 - B800BUSCAL5SJCR0

BUSULFAN CALIBRATOR LEVEL 5
UTAK LABORATORIES, INC.
BUS CAL 5 SJCR
In Commercial Distribution

  • B800BUSCAL5SJCR5 ()
  • B800BUSCAL5SJCR0 ()

  • Total Volume: 5 Milliliter
BUS CAL 5 SJCR

  • Multiple drugs of abuse IVD, control

Validity Control Level 5 - B800170140

Validity Control Level 5
UTAK LABORATORIES, INC.
17014
In Commercial Distribution

  • B800170140 ()
  • B800170145 ()

  • Total Volume: 25 Milliliter
17014

  • Multiple urine analyte IVD, control

DAU CALIBRATOR LEVEL 5 - B80004240000050

No Description
UTAK LABORATORIES, INC.
DAU CAL 5 V4 F SEMCE
In Commercial Distribution

  • B80004240000050 ()
  • B80004240000051 ()
  • B80004240000052 ()
  • B80004240000053 ()
  • B80004240000056 ()
  • B80004240000057 ()
  • B80004240000058 ()


  • Multiple therapeutic drugs/drugs of abuse IVD, control

MORPHINE 5 NG/M - B800POSM24512ML0

MORPHINE 5 NG/M
UTAK LABORATORIES, INC.
pos-m245-1-2ml
In Commercial Distribution

  • B800POSM24512ML0 ()

  • Total Volume: 2 Milliliter
pos-m245-1-2ml

  • Multiple-therapy therapeutic drug monitoring IVD, control

ETG PLUS CALIBRATOR 5 - B800ETGCAL5UFNPIL0

ETG PLUS CALIBRATOR 5
UTAK LABORATORIES, INC.
ETG+ CAL 5 U F NPIL
In Commercial Distribution

  • B800ETGCAL5UFNPIL5 ()
  • B800ETGCAL5UFNPIL0 ()

  • Total Volume: 2 Milliliter
ETG+ CAL 5 U F NPIL

  • Multiple-type clinical chemistry analyte profile IVD, control
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