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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STATION
Exactech, Inc.
I00020
In Commercial Distribution

  • 10885862252821 ()

  • V2
I00020

  • Robotic surgical navigation system
TRAVEL CASE
Exactech, Inc.
I00022
In Commercial Distribution

  • 10885862266675 ()

  • V2
I00022

  • Robotic surgical navigation system
POWER SUPPLY
Exactech, Inc.
I00021
In Commercial Distribution

  • 10885862266668 ()

  • V2
I00021

  • Robotic surgical navigation system
IMPLANT KIT
Exactech, Inc.
A10012
In Commercial Distribution

  • 10885862266651 ()

  • V2
A10012

  • Robotic surgical navigation system
STATION2+
Exactech, Inc.
I00025
In Commercial Distribution

  • 10885862574091 ()

  • V2
I00025

  • Robotic surgical navigation system
MOBILE CART
Exactech, Inc.
J00120
In Commercial Distribution

  • 10885862553331 ()

  • V2
J00120

  • Robotic surgical navigation system
Mounting Arm – Upper Part 4 positions
Exactech, Inc.
J00065
In Commercial Distribution

  • 10885862625601 ()

  • V2
J00065

  • Robotic surgical navigation system
No Description
Zhejiang Shuyou Surgical Instrument Co.,Ltd.
ⅥW-T003注吹钨丝
In Commercial Distribution

  • 06924274950103 ()


  • Open-surgery electrosurgical electrode, monopolar, single-use
No Description
Zhejiang Shuyou Surgical Instrument Co.,Ltd.
ⅥS-T002吹管钨丝
In Commercial Distribution

  • 06924274950059 ()


  • Open-surgery electrosurgical electrode, monopolar, single-use
No Description
Zhejiang Shuyou Surgical Instrument Co.,Ltd.
ⅥM-T001注塑钨丝
In Commercial Distribution

  • 06924274950004 ()


  • Open-surgery electrosurgical electrode, monopolar, single-use
BBL V2
MEDLINE INDUSTRIES, INC.
DYNJ84672
In Commercial Distribution

  • 40195327397846 ()
  • 10195327397845 ()
DYNJ84672

  • General surgical procedure kit, non-medicated, single-use
Version V2
ESAOTE SPA
101640002
In Commercial Distribution

  • 08056304452597 ()


  • General-purpose ultrasound imaging system
Version V2
ESAOTE SPA
100642501
In Commercial Distribution

  • 08056304453037 ()


  • General-purpose ultrasound imaging system
Ver. V2
Esaote Europe B.V.
102642001
In Commercial Distribution

  • 08056304453020 ()


  • General-purpose ultrasound imaging system
GLUCURONIDES V2
UTAK LABORATORIES, INC.
GLUC U V2 F ACL
In Commercial Distribution

  • B800GLUCUV2FACL5 ()
  • B800GLUCUV2FACL0 ()

  • Total Volume: 3 Milliliter
GLUC U V2 F ACL

  • Multiple-type clinical chemistry analyte profile IVD, control
Twin-Pass V2
TELEFLEX INCORPORATED
IPN916104
In Commercial Distribution

  • 20841156107397 ()
  • 10841156107390 ()
5200

  • Peripheral vascular intervention infusion catheter
Minnie V2
TELEFLEX INCORPORATED
IPN039089
In Commercial Distribution

  • 20841156103429 ()
  • 10841156103422 ()

  • Length: 150 Centimeter
  • 0.035 inch guidewire compatibility
5713

  • Peripheral vascular intervention infusion catheter
Minnie V2
TELEFLEX INCORPORATED
IPN039088
In Commercial Distribution

  • 20841156103412 ()
  • 10841156103415 ()

  • Length: 135 Centimeter
  • 0.035 inch guidewire compatibility
5712

  • Peripheral vascular intervention infusion catheter
Minnie V2
TELEFLEX INCORPORATED
IPN039087
In Commercial Distribution

  • 20841156103405 ()
  • 10841156103408 ()

  • Length: 150 Centimeter
  • 0.014 inch guidewire compatibility
5711

  • Peripheral vascular intervention infusion catheter
Minnie V2
TELEFLEX INCORPORATED
IPN039086
In Commercial Distribution

  • 20841156103399 ()
  • 10841156103392 ()

  • 0.014 inch guidewire compatibility
  • Length: 135 Centimeter
5710

  • Peripheral vascular intervention infusion catheter
T-HANDLE V2
TORNIER
MWB337
In Commercial Distribution

  • 03700386970184 ()

  • SZH
MWB337

  • Surgical instrument handle, non-torque-limiting
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
TRIAL PACK V2
MEDLINE INDUSTRIES, INC.
DYNJ86512
In Commercial Distribution

  • 40195327644971 ()
  • 10195327644970 ()
DYNJ86512

  • General surgical procedure kit, non-medicated, single-use
IMPIX-TLIF HOLDER v2
MEDICREA INTERNATIONAL
A15130030
Not in Commercial Distribution

  • 03613720217497 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
GL-MT300N V2 Router
Nds Surgical Imaging LLC
WIFIKIT1M
Not in Commercial Distribution

  • 00817613021304 ()


  • Electrical mains power extension cable
  • Electrical-only medical device connection cable, 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
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
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
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
Metatarsal Pad V2
VIVE HEALTH LLC
INS1043
In Commercial Distribution

  • 10818323028505 ()
  • 00818323028508 ()


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

  • B581LIFESYSPACSV20 ()


  • Radiological PACS software
PAIN V2 TRAY
Cardinal Health 200, LLC
34-3489A
In Commercial Distribution

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

  • Cervical anaesthesia kit
Grael v2 Assembly
COMPUMEDICS LIMITED
Grael
In Commercial Distribution

  • 09342451001269 ()
8028-0001-02

  • Electroencephalograph
  • Polysomnograph
OMNIBotics, Nanoblock V2
Omni Life Science, Inc.
NS-40400
In Commercial Distribution

  • 00841690194194 ()
NS-40400

  • Orthopaedic prosthesis implantation positioning instrument, 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
Water Pillow (V2)
VIVE HEALTH LLC
CSH1065WHT
In Commercial Distribution

  • 10810041983920 ()
  • 00810041983923 ()


  • Water-filled chair cushion
COUNTER TENSIONER V2
ZIMMER BIOMET INC
230H3002
In Commercial Distribution

  • 00887868227394 ()


  • Spinal dynamic-stabilization system
V2 Bladed Trocar
Covidien LP
179097P
In Commercial Distribution

  • 10884521081321 ()
  • 20884521081328 ()

  • Outer Diameter: 5 Millimeter
  • Outer Diameter: 12 Millimeter
  • length,long,n/a;


  • Laparoscopic multi-instrument access port, single-use
V2 Bladed Trocar
Covidien LP
179096P
In Commercial Distribution

  • 10884521081307 ()
  • 20884521081304 ()

  • Outer Diameter: 12 Millimeter
  • Outer Diameter: 5 Millimeter


  • Laparoscopic multi-instrument access port, single-use
V2 Bladed Trocar
Covidien LP
179095P
In Commercial Distribution

  • 10884521081284 ()
  • 20884521081281 ()

  • Outer Diameter: 5 Millimeter
  • Outer Diameter: 11 Millimeter


  • Laparoscopic multi-instrument access port, single-use
V2 Bladed Trocar
Covidien LP
179094
In Commercial Distribution

  • 10884521081260 ()
  • 20884521081267 ()

  • Outer Diameter: 5 Millimeter


  • Laparoscopic multi-instrument access port, single-use
V2 Bladed Trocar
Covidien LP
179093
Not in Commercial Distribution

  • 10884521081246 ()
  • 20884521081243 ()

  • length,short,n/a;
  • Outer Diameter: 5 Millimeter


  • Laparoscopic multi-instrument access port, single-use
R350 V2 Guidewire
TELEFLEX INCORPORATED
IPN913606
In Commercial Distribution

  • 50841156101174 ()
  • 60841156101171 ()

  • Length: 350 Centimeter
7390

  • Cardiac/peripheral vascular guidewire, single-use
V2 4-PORT MANIFOLD
STRYKER CORPORATION
0750400000
In Commercial Distribution

  • 37613327563833 ()
  • 07613327563832 ()
0750400000

  • Surgical fluid/smoke waste management system
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