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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Minnie V2
TELEFLEX INCORPORATED
IPN039086
In Commercial Distribution

  • 20841156103399 ()
  • 10841156103392 ()

  • 0.014 inch guidewire compatibility
  • Length: 135 Centimeter
5710

  • Peripheral vascular intervention infusion catheter
Dental LT Clear V2 for cartridge V2
FORMLABS OHIO INC.
FLDLCL02
In Commercial Distribution

  • 00850061175076 ()


  • Dental appliance fabrication material, resin
MNA-240 DEC V2
Barco NV
MNA-240
In Commercial Distribution

  • 05415334001619 ()
K9303270A

  • Operating room audiovisual data/device management system
Grael v2 Assembly
COMPUMEDICS LIMITED
Grael
In Commercial Distribution

  • 09342451001269 ()
8028-0001-02

  • Electroencephalograph
  • Polysomnograph
TRIAL PACK V2
MEDLINE INDUSTRIES, INC.
DYNJ86512
In Commercial Distribution

  • 40195327644971 ()
  • 10195327644970 ()
DYNJ86512

  • General surgical procedure kit, non-medicated, single-use
PAIN V2 TRAY
Cardinal Health 200, LLC
34-3489A
In Commercial Distribution

  • 50887488615699 ()
  • 10887488615691 ()
34-3489A

  • Cervical anaesthesia kit
OMNIBotics, Nanoblock V2
Omni Life Science, Inc.
NS-40400
In Commercial Distribution

  • 00841690194194 ()
NS-40400

  • Orthopaedic prosthesis implantation positioning instrument, reusable
BUPRENORPHINE GLUCURONIDE V2
UTAK LABORATORIES, INC.
BUP GLUC+ QC V2 U F HCMC
In Commercial Distribution

  • B800BUPGLUCQCV2UFHCMC5 ()
  • B800BUPGLUCQCV2UFHCMC0 ()

  • Total Volume: 2 Milliliter
BUP GLUC+ QC V2 U F HCMC

  • Multiple-type clinical chemistry analyte profile IVD, control
DAU POSITIVE V2
UTAK LABORATORIES, INC.
DAU POS F V2 UVHS
In Commercial Distribution

  • B800DAUPOSFV2UVHS5 ()
  • B800DAUPOSFV2UVHS0 ()

  • Total Volume: 5 Milliliter
DAU POS F V2 UVHS

  • Multiple drugs of abuse IVD, control
DAU NEGATIVE V2
UTAK LABORATORIES, INC.
DAU NEG F V2 UVHS
In Commercial Distribution

  • B800DAUNEGFV2UVHS5 ()
  • B800DAUNEGFV2UVHS0 ()

  • Total Volume: 5 Milliliter
DAU NEG F V2 UVHS

  • Multiple drugs of abuse IVD, control
FLURAZEPAM PLUS V2
UTAK LABORATORIES, INC.
FLURAZ+ U F V2 SWI
In Commercial Distribution

  • B800FLURAZUFV2SWI5 ()
  • B800FLURAZUFV2SWI0 ()

  • Total Volume: 5 Milliliter
FLURAZ+ U F V2 SWI

  • Multiple-type clinical chemistry analyte profile IVD, control
BPM Silver V2
VIVE HEALTH LLC
DMD1001SLV
In Commercial Distribution

  • 10818323026631 ()
  • 00818323026634 ()


  • Physiologic-monitoring defibrillation system
BPM Black V2
VIVE HEALTH LLC
DMD1001BLK
In Commercial Distribution

  • 10818323026624 ()
  • 00818323026627 ()


  • Physiologic-monitoring defibrillation system
Metatarsal Pad V2
VIVE HEALTH LLC
INS1043
In Commercial Distribution

  • 10818323028505 ()
  • 00818323028508 ()


  • Foot friction/impact protector
LIFESYS PACS v2
LIFETRACK MEDICAL SYSTEMS INC.
2
In Commercial Distribution

  • B581LIFESYSPACSV20 ()


  • Radiological PACS software
IMPIX-TLIF HOLDER v2
MEDICREA INTERNATIONAL
A15130030
Not in Commercial Distribution

  • 03613720217497 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
Owandy-CR V2 Ethernet
OWANDY RADIOLOGY
Owandy-CR
In Commercial Distribution

  • 03760262652351 ()
9458900031

  • Digital imaging cassette/storage phosphor screen, dental
Owandy-CR V2 USB
OWANDY RADIOLOGY
Owandy-CR
In Commercial Distribution

  • 03760262652337 ()
9458900021

  • Digital imaging cassette/storage phosphor screen, dental
Twin-Pass V2, 3.5F
TELEFLEX INCORPORATED
IPN913543
In Commercial Distribution

  • 30841156100357 ()
  • 10841156100353 ()
5200

  • Peripheral vascular intervention infusion catheter
R350 V2 Guidewire
TELEFLEX INCORPORATED
IPN913606
In Commercial Distribution

  • 30841156101170 ()
  • 10841156101176 ()

  • Length: 350 Centimeter
7390

  • Cardiac/peripheral vascular guidewire, single-use
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