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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DRUGS OF ABUSE LEVEL 2 V2
UTAK LABORATORIES, INC.
DAU QC 2 V2 F NHI
In Commercial Distribution

  • B800DAUQC2V2FNHI5 ()
  • B800DAUQC2V2FNHI0 ()

  • Total Volume: 1 Milliliter
DAU QC 2 V2 F NHI

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE LEVEL 1 V2
UTAK LABORATORIES, INC.
DAU QC 1 V2 F NHI
In Commercial Distribution

  • B800DAUQC1V2FNHI5 ()
  • B800DAUQC1V2FNHI0 ()

  • Total Volume: 1 Milliliter
DAU QC 1 V2 F NHI

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE NEGATIVE SCREEN V2
UTAK LABORATORIES, INC.
DAU NEG V2 U F PHHC
In Commercial Distribution

  • B800DAUNEGV2UFPHHC5 ()
  • B800DAUNEGV2UFPHHC0 ()

  • Total Volume: 3 Milliliter
DAU NEG V2 U F PHHC

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE LEVEL 2 V2
UTAK LABORATORIES, INC.
DAU 2 V2 F SNC
In Commercial Distribution

  • B800DAU2V2FSNC5 ()
  • B800DAU2V2FSNC0 ()

  • Total Volume: 3 Milliliter
DAU 2 V2 F SNC

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE LEVEL 2 V2
UTAK LABORATORIES, INC.
DAU 2 V2 F CSL
In Commercial Distribution

  • B800DAU2V2FCSL5 ()
  • B800DAU2V2FCSL0 ()

  • Total Volume: 10 Milliliter
DAU 2 V2 F CSL

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE LEVEL 1 V2
UTAK LABORATORIES, INC.
DAU 1 V2 F SNC
In Commercial Distribution

  • B800DAU1V2FSNC5 ()
  • B800DAU1V2FSNC0 ()

  • Total Volume: 3 Milliliter
DAU 1 V2 F SNC

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE LEVEL 1 V2
UTAK LABORATORIES, INC.
DAU 1 V2 F CSL
In Commercial Distribution

  • B800DAU1V2FCSL5 ()
  • B800DAU1V2FCSL0 ()

  • Total Volume: 10 Milliliter
DAU 1 V2 F CSL

  • Multiple-type clinical chemistry analyte profile IVD, control
Insert Trial V2 Size 4 6mm
Ortho Development Corporation
C-1773-06
In Commercial Distribution

  • 00822409116799 ()

  • Height: 6 Millimeter


  • Knee tibia prosthesis trial, reusable
Insert Trial V2 Size 5 6mm
Ortho Development Corporation
C-1774-06
In Commercial Distribution

  • 00822409116782 ()

  • Height: 6 Millimeter


  • Knee tibia prosthesis trial, reusable
TRIAL, REVELATION V2 NECK, SIZE16.5, RT
Encore Medical, L.P.
803-04-088
In Commercial Distribution

  • 00888912091497 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
TRIAL, REVELATION V2 NECK, SIZE15, RT
Encore Medical, L.P.
803-04-087
In Commercial Distribution

  • 00888912091480 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
TRIAL, REVELATION V2 NECK, SIZE13.5, RT
Encore Medical, L.P.
803-04-086
In Commercial Distribution

  • 00888912091473 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
TRIAL, REVELATION V2 NECK, SIZE12, RT
Encore Medical, L.P.
803-04-085
In Commercial Distribution

  • 00888912091466 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
TRIAL, REVELATION V2 NECK, SIZE10.5, RT
Encore Medical, L.P.
803-04-084
In Commercial Distribution

  • 00888912091459 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
TRIAL, REVELATION V2 NECK, SIZE9, RT
Encore Medical, L.P.
803-04-083
In Commercial Distribution

  • 00888912091442 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
TRIAL, REVELATION V2 NECK, SIZE8, RT
Encore Medical, L.P.
803-04-082
In Commercial Distribution

  • 00888912091435 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
TRIAL, REVELATION V2 NECK, SIZE16.5, LT
Encore Medical, L.P.
803-04-080
In Commercial Distribution

  • 00888912091411 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
TRIAL, REVELATION V2 NECK, SIZE15, LT
Encore Medical, L.P.
803-04-079
In Commercial Distribution

  • 00888912091404 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
TRIAL, REVELATION V2 NECK, SIZE13.5, LT
Encore Medical, L.P.
803-04-078
In Commercial Distribution

  • 00888912091398 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
TRIAL, REVELATION V2 NECK, SIZE12, LT
Encore Medical, L.P.
803-04-077
In Commercial Distribution

  • 00888912091381 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
TRIAL, REVELATION V2 NECK, SIZE10.5, LT
Encore Medical, L.P.
803-04-076
In Commercial Distribution

  • 00888912091374 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
TRIAL, REVELATION V2 NECK, SIZE9, LT
Encore Medical, L.P.
803-04-075
In Commercial Distribution

  • 00888912091367 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
TRIAL, REVELATION V2 NECK, SIZE8, LT
Encore Medical, L.P.
803-04-074
In Commercial Distribution

  • 00888912091350 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
SMS Solid Stem V2 LAT #2
Medacta International SA
01.36.077
In Commercial Distribution

  • 07630971292062 ()


  • Press-fit hip femur prosthesis, one-piece
SMS Solid Stem V2 LAT #1
Medacta International SA
01.36.076
In Commercial Distribution

  • 07630971292055 ()


  • Press-fit hip femur prosthesis, one-piece
SMS Solid Stem V2 STD #2
Medacta International SA
01.36.057
In Commercial Distribution

  • 07630971292024 ()


  • Press-fit hip femur prosthesis, one-piece
SMS Solid Stem V2 STD #1
Medacta International SA
01.36.056
In Commercial Distribution

  • 07630971292017 ()


  • Press-fit hip femur prosthesis, one-piece
SMS Solid manual broach V2 # 2
Medacta International SA
01.36.10.0165
In Commercial Distribution

  • 07630971290013 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
SMS Solid manual broach V2 # 1
Medacta International SA
01.36.10.0164
In Commercial Distribution

  • 07630971290006 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
MASK ADPT V2 22ID MACH POM
HANS RUDOLPH, INC.
6450
In Commercial Distribution

  • 00817136027586 ()
613010

  • Pulmonary function valve
SMALL ADJULT GH POLYNET V2 CLIPS
HANS RUDOLPH, INC.
7450
In Commercial Distribution

  • 00817136027548 ()
201079A

  • Pulmonary function valve
MASK ADPT V2 FLEXIBLE 1.25",6450"
HANS RUDOLPH, INC.
6450
In Commercial Distribution

  • 00817136027463 ()
CC1885

  • Pulmonary function valve
SWIVEL PORT V2 QREL 22ID PCYEL
HANS RUDOLPH, INC.
7700
Not in Commercial Distribution

  • 00817136027289 ()
612780

  • CPAP/BPAP face mask, reusable
LOWER STRAP CLIP V2 MASK BRACE
HANS RUDOLPH, INC.
7600
In Commercial Distribution

  • 00817136027197 ()
171473

  • CPAP/BPAP face mask, reusable
UPPER STRAP CLIP V2 MASK BRACE
HANS RUDOLPH, INC.
7600
In Commercial Distribution

  • 00817136027180 ()
171470

  • CPAP/BPAP face mask, reusable
ETG PLUS QC LEVEL 3 V2
UTAK LABORATORIES, INC.
ETG+ QC 3 V2 U F UCSF
In Commercial Distribution

  • B800ETGQC3V2UFUCSF5 ()
  • B800ETGQC3V2UFUCSF0 ()

  • Total Volume: 1 Milliliter
ETG+ QC 3 V2 U F UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control
ETG PLUS QC LEVEL 2 V2
UTAK LABORATORIES, INC.
ETG+ QC 2 V2 U F UCSF
In Commercial Distribution

  • B800ETGQC2V2UFUCSF5 ()
  • B800ETGQC2V2UFUCSF0 ()

  • Total Volume: 1 Milliliter
ETG+ QC 2 V2 U F UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control
MectaLIF PLIF 9mm Trials Caddy V2
Medacta International SA
03.22.10.0315
In Commercial Distribution

  • 07630345749772 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
MectaLIF Posterior Trial 11x25x15 L12° V2
Medacta International SA
03.22.10.3590
In Commercial Distribution

  • 07630345745583 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
MectaLIF Posterior Trial 11x25x14 L12° V2
Medacta International SA
03.22.10.3589
In Commercial Distribution

  • 07630345745576 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
MectaLIF Posterior Trial 11x25x13 L12° V2
Medacta International SA
03.22.10.3588
In Commercial Distribution

  • 07630345745569 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
MectaLIF Posterior Trial 11x25x12 L12° V2
Medacta International SA
03.22.10.3587
In Commercial Distribution

  • 07630345745552 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
MectaLIF Posterior Trial 11x22x15 L12° V2
Medacta International SA
03.22.10.3586
In Commercial Distribution

  • 07630345745545 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
MectaLIF Posterior Trial 11x22x14 L12° V2
Medacta International SA
03.22.10.3585
In Commercial Distribution

  • 07630345745538 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
MectaLIF Posterior Trial 11x22x13 L12° V2
Medacta International SA
03.22.10.3584
In Commercial Distribution

  • 07630345745521 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
MectaLIF Posterior Trial 11x22x12 L12° V2
Medacta International SA
03.22.10.3583
In Commercial Distribution

  • 07630345745514 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
MectaLIF Posterior Trial 11x22x11 L12° V2
Medacta International SA
03.22.10.3582
In Commercial Distribution

  • 07630345745507 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
MectaLIF Posterior Trial 11x19x15 L12° V2
Medacta International SA
03.22.10.3581
In Commercial Distribution

  • 07630345745491 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
MectaLIF Posterior Trial 11x19x14 L12° V2
Medacta International SA
03.22.10.3580
In Commercial Distribution

  • 07630345745484 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
MectaLIF Posterior Trial 11x19x13 L12° V2
Medacta International SA
03.22.10.3579
In Commercial Distribution

  • 07630345745477 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
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