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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FlexStep V2, 700, 6 step, outdoor
Liftup A/S
FlexStep V2
In Commercial Distribution

  • 05714420070646 ()
107064

  • Assistive passenger lift
FlexStep V2, 700, 5 step, outdoor
Liftup A/S
FlexStep V2
In Commercial Distribution

  • 05714420070639 ()
107063

  • Assistive passenger lift
FlexStep V2, 800, 5 step, outdoor
Liftup A/S
FlexStep V2
In Commercial Distribution

  • 05714420070622 ()
107062

  • Assistive passenger lift
FlexStep V2, 700, 4 step, outdoor
Liftup A/S
FlexStep V2
In Commercial Distribution

  • 05714420070486 ()
107048

  • Assistive passenger lift
FlexStep V2, 800, 6 step, outdoor
Liftup A/S
FlexStep V2
In Commercial Distribution

  • 05714420047785 ()
104778

  • Assistive passenger lift
FlexStep V2, 700, 3 step,, outdoor
Liftup A/S
FlexStep V2
In Commercial Distribution

  • 05714420047242 ()
104724

  • Assistive passenger lift
Upper Assy, 3T IOH V2, 110833-000
IMRIS Imaging, Inc.
HC300 Upper Assy
In Commercial Distribution

  • 00857534006233 ()


  • MRI system coil, radio-frequency
Lower Assy, 3T IOH V2, 110840-000
IMRIS Imaging, Inc.
HC300 Lower Coil
In Commercial Distribution

  • 00857534006226 ()


  • MRI system coil, radio-frequency
GeneChip™ Fluidics Station FS450Dx v2
Affymetrix, Inc.
00-0335
In Commercial Distribution

  • 00856826006029 ()
00-0335

  • Microarray analyser IVD
Lower Assy, 3T IOH V2, 110840-600
IMRIS Imaging, Inc.
HC300 Lower Coil
In Commercial Distribution

  • 00857534006424 ()


  • MRI system coil, radio-frequency
Upper Assy, 3T IOH V2, 110833-600
IMRIS Imaging, Inc.
HC300 Upper Assy
In Commercial Distribution

  • 00857534006417 ()


  • MRI system coil, radio-frequency
Surgical Guide Resin for cartridge V2
FORMLABS OHIO INC.
FLSGAM01
In Commercial Distribution

  • 00850061175090 ()


  • Dental appliance fabrication material, resin
IBT Flex Resin for cartridge V2
FORMLABS OHIO INC.
FLIBFL01
In Commercial Distribution

  • 00850061175083 ()


  • Dental appliance fabrication material, resin
Custom Tray Resin for cartridge v2
FORMLABS OHIO INC.
FLCTBL01
In Commercial Distribution

  • 00850061175069 ()


  • Dental appliance fabrication material, resin
SA5 CIC, V2 BE SAPHIRA 5
Bernafon AG
170586
In Commercial Distribution

  • 05711584063033 ()


  • Air-conduction hearing aid, canal
SA5 IIC, V2 BL SAPHIRA 5
Bernafon AG
170071
In Commercial Distribution

  • 05711584062999 ()


  • Air-conduction hearing aid, canal
CR40 CIC, V2 BE CHEER 40
Sonic Innovations, Inc.
170591
In Commercial Distribution

  • 05711583028378 ()


  • Air-conduction hearing aid, canal
CR60 CIC, V2 BE CHEER 60
Sonic Innovations, Inc.
170590
In Commercial Distribution

  • 05711583028361 ()


  • Air-conduction hearing aid, canal
CL80 CIC, V2 BE CELEBRATE 80
Bernafon AG
170589
In Commercial Distribution

  • 05711583028354 ()


  • Air-conduction hearing aid, canal
CL100 CIC, V2 BE CELEBRATE 100
Bernafon AG
170588
In Commercial Distribution

  • 05711583028347 ()


  • Air-conduction hearing aid, canal
CR60 IIC, V2 BL CHEER 60
Sonic Innovations, Inc.
170081
In Commercial Distribution

  • 05711583028330 ()


  • Air-conduction hearing aid, canal
CL100 IIC, V2 BL CELEBRATE 100
Bernafon AG
170078
In Commercial Distribution

  • 05711583028323 ()


  • Air-conduction hearing aid, canal
SA3 CIC, V2 BE SAPHIRA 3
Bernafon AG
170587
In Commercial Distribution

  • 05711584063040 ()


  • Air-conduction hearing aid, canal
JU7 CIC, V2 BE JUNA 7
Bernafon AG
170585
In Commercial Distribution

  • 05711584063026 ()


  • Air-conduction hearing aid, canal
JU9 CIC, V2 BE JUNA 9
Bernafon AG
170584
In Commercial Distribution

  • 05711584063019 ()


  • Air-conduction hearing aid, canal
JU9 IIC, V2 BL JUNA 9
Bernafon AG
170069
In Commercial Distribution

  • 05711584062982 ()


  • Air-conduction hearing aid, canal
SURELOCK, V2 -BULK ELECTRODE 50 PK
CURBELL MEDICAL PRODUCTS, INC.
CL-A60/V2
In Commercial Distribution

  • 00840828140683 ()
6104

  • Electrocardiographic electrode connector
SURELOCK V2 CONNECTOR CURB. - 5 PACK
CURBELL MEDICAL PRODUCTS, INC.
CL-A60/5/V2
Not in Commercial Distribution

  • 00840828140621 ()
6098

  • Electrocardiographic electrode, reusable
R-800um SHP v2 Assy Light Force
DJO, LLC
PRD-000758-010-00-L-R
In Commercial Distribution

  • 00190446887195 ()


  • Musculoskeletal/physical therapy laser beam guide, transcutaneous
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
BLACKHAWK TI,INSERTER,MAIN CORE V2
Choice Spine, LP
T070-0001-A3
In Commercial Distribution

  • 00840996192408 ()


  • Surgical implant/trial-implant/sizer holder, reusable
EGPS, SCREW SHANK DRIVER V2, T27
HYHTE HOLDINGS, INC.
NZA033000
In Commercial Distribution

  • 00840085276521 ()

  • Length: 60 Millimeter
  • Outer Diameter: 8.5 Millimeter
NZA033000

  • Bone tap, reusable
PEDICLE SCREWDRIVER SHAFT FOR PASS V2
MEDICREA INTERNATIONAL
A99090210
Not in Commercial Distribution

  • 03613720222194 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
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
TRACE ELEMENTS QC LEVEL 2 V2
UTAK LABORATORIES, INC.
TRACE QC 2 V2 S PAML
In Commercial Distribution

  • B800TRACEQC2V2SPAML5 ()
  • B800TRACEQC2V2SPAML0 ()

  • Total Volume: 5 Milliliter
TRACE QC 2 V2 S PAML

  • Multiple-type clinical chemistry analyte profile IVD, control
TRACE ELEMENTS QC LEVEL 1 V2
UTAK LABORATORIES, INC.
TRACE QC 1 V2 S PAML
In Commercial Distribution

  • B800TRACEQC1V2SPAML5 ()
  • B800TRACEQC1V2SPAML0 ()

  • Total Volume: 5 Milliliter
TRACE QC 1 V2 S PAML

  • Multiple-type clinical chemistry analyte profile IVD, control
NICOTINE PLUS 1200 NG/ML V2
UTAK LABORATORIES, INC.
NICO+ 1200 V2 U F UWHC
In Commercial Distribution

  • B800NICO1200V2UFUWHC5 ()
  • B800NICO1200V2UFUWHC0 ()

  • Total Volume: 5 Milliliter
NICO+ 1200 V2 U F UWHC

  • Multiple-type clinical chemistry analyte profile IVD, control
NICOTINE PLUS 100 NG/ML V2
UTAK LABORATORIES, INC.
NICO+ 100 V2 U F UWHC
In Commercial Distribution

  • B800NICO100V2UFUWHC0 ()
  • B800NICO100V2UFUWHC5 ()

  • Total Volume: 5 Milliliter
NICO+ 100 V2 U F UWHC

  • Multiple-type clinical chemistry analyte profile IVD, control
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
ETG PLUS QC LEVEL 1 V2
UTAK LABORATORIES, INC.
ETG+ QC 1 V2 U F UCSF
In Commercial Distribution

  • B800ETGQC1V2UFUCSF5 ()
  • B800ETGQC1V2UFUCSF0 ()

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

  • Multiple-type clinical chemistry analyte profile IVD, control
DRUGS OF ABUSE LEVEL 3 V2
UTAK LABORATORIES, INC.
DAU QC 3 V2 F NHI
In Commercial Distribution

  • B800DAUQC3V2FNHI5 ()
  • B800DAUQC3V2FNHI0 ()

  • Total Volume: 1 Milliliter
DAU QC 3 V2 F NHI

  • Multiple-type clinical chemistry analyte profile IVD, control
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
MASK ADPT V2 22ID MACH POM
HANS RUDOLPH, INC.
6450
In Commercial Distribution

  • 00817136027586 ()
613010

  • Pulmonary function valve
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