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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Trial Neck v2 STD #1
Medacta International SA
01.18.10.061
In Commercial Distribution

  • 07630040751674 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
REVELATION V2 OSTEOTOMY GUIDE, SIZE8
Encore Medical, L.P.
803-04-151
In Commercial Distribution

  • 00888912091817 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
REVELATION V2 OSTEOTOMY GUIDE, SIZE16.5
Encore Medical, L.P.
803-04-120
In Commercial Distribution

  • 00888912091732 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
REVELATION V2 OSTEOTOMY GUIDE, SIZE15
Encore Medical, L.P.
803-04-119
In Commercial Distribution

  • 00888912091725 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
REVELATION V2 OSTEOTOMY GUIDE, SIZE13.5
Encore Medical, L.P.
803-04-118
In Commercial Distribution

  • 00888912091718 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
REVELATION V2 OSTEOTOMY GUIDE, SIZE12
Encore Medical, L.P.
803-04-117
In Commercial Distribution

  • 00888912091701 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
REVELATION V2 OSTEOTOMY GUIDE, SIZE10.5
Encore Medical, L.P.
803-04-116
In Commercial Distribution

  • 00888912091695 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
REVELATION V2 OSTEOTOMY GUIDE, SIZE9
Encore Medical, L.P.
803-04-115
In Commercial Distribution

  • 00888912091688 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
MASK ADPT V2 22ID POLYS
HANS RUDOLPH, INC.
7450
In Commercial Distribution

  • 00817136027326 ()
612857

  • Pulmonary function valve
LEFLUNOMIDE V2 LOW LEVEL 3
UTAK LABORATORIES, INC.
LEFLU V2 L L3
In Commercial Distribution

  • B800LEFLUV2LL35 ()
  • B800LEFLUV2LL30 ()

  • Total Volume: .5 Milliliter
LEFLU V2 L L3

  • Multiple-type clinical chemistry analyte profile IVD, control
LEFLUNOMIDE V2 LOW LEVEL 2
UTAK LABORATORIES, INC.
LEFLU V2 L L2
In Commercial Distribution

  • B800LEFLUV2LL25 ()
  • B800LEFLUV2LL20 ()

  • Total Volume: .5 Milliliter
LEFLU V2 L L2

  • Multiple-type clinical chemistry analyte profile IVD, control
LEFLUNOMIDE V2 LOW LEVEL 1
UTAK LABORATORIES, INC.
LEFLU V2 L L1
In Commercial Distribution

  • B800LEFLUV2LL15 ()
  • B800LEFLUV2LL10 ()

  • Total Volume: .5 Milliliter
LEFLU V2 L L1

  • Multiple-type clinical chemistry analyte profile IVD, control
ISAVUCONAZOLE PLUS CONTROL 3 V2
UTAK LABORATORIES, INC.
ISA+ CONT 3 V2 S F UCSF
In Commercial Distribution

  • B800ISACONT3V2SFUCSF5 ()
  • B800ISACONT3V2SFUCSF0 ()

  • Total Volume: 1 Milliliter
ISA+ CONT 3 V2 S F UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control
ISAVUCONAZOLE PLUS CONTROL 2 V2
UTAK LABORATORIES, INC.
ISA+ CONT 2 V2 S F UCSF
In Commercial Distribution

  • B800ISACONT2V2SFUCSF5 ()
  • B800ISACONT2V2SFUCSF0 ()

  • Total Volume: 1 Milliliter
ISA+ CONT 2 V2 S F UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control
ISAVUCONAZOLE PLUS CONTROL 1 V2
UTAK LABORATORIES, INC.
ISA+ CONT 1 V2 S F UCSF
In Commercial Distribution

  • B800ISACONT1V2SFUCSF5 ()
  • B800ISACONT1V2SFUCSF0 ()

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

  • Multiple-type clinical chemistry analyte profile IVD, control
ISAVUCONAZOLE PLUS CALIBRATOR 6 V2
UTAK LABORATORIES, INC.
ISA+ CAL 6 V2 S F UCSF
In Commercial Distribution

  • B800ISACAL6V2SFUCSF5 ()
  • B800ISACAL6V2SFUCSF0 ()

  • Total Volume: 1 Milliliter
ISA+ CAL 6 V2 S F UCSF

  • 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
ISAVUCONAZOLE PLUS CALIBRATOR 4 V2
UTAK LABORATORIES, INC.
ISA+ CAL 4 V2 S F UCSF
In Commercial Distribution

  • B800ISACAL4V2SFUCSF5 ()
  • B800ISACAL4V2SFUCSF0 ()

  • Total Volume: 1 Milliliter
ISA+ CAL 4 V2 S F UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control
ISAVUCONAZOLE PLUS CALIBRATOR 3 V2
UTAK LABORATORIES, INC.
ISA+ CAL 3 V2 S F UCSF
In Commercial Distribution

  • B800ISACAL3V2SFUCSF5 ()
  • B800ISACAL3V2SFUCSF0 ()

  • Total Volume: 1 Milliliter
ISA+ CAL 3 V2 S F UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control
ISAVUCONAZOLE PLUS CALIBRATOR 2 V2
UTAK LABORATORIES, INC.
ISA+ CAL 2 V2 S F UCSF
In Commercial Distribution

  • B800ISACAL2V2SFUCSF5 ()
  • B800ISACAL2V2SFUCSF0 ()

  • Total Volume: 1 Milliliter
ISA+ CAL 2 V2 S F UCSF

  • Multiple-type clinical chemistry analyte profile IVD, control
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