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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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CARDINAL HEALTH - 20885380096737

CRYPTO GIARDIA KIT
Cardinal Health 200, LLC
CH6830
In Commercial Distribution

  • 50885380096738 ()
  • 20885380096737 ()
  • 10885380096730 ()
CH6830

  • Multiple faecal parasite antigen IVD, kit, rapid ICT, clinical

NA - 00848838026874

Xpect Giardia/Crypto KT/20TST
REMEL, INC.
R2450520
In Commercial Distribution

  • 00848838026874 ()
  • 00848838099779 ()


  • Multiple faecal parasite antigen IVD, kit, rapid ICT, clinical

N/A - 00810047420804

Crypto Kinyoun Decolorizer [250ml x 6 bottles/pkg]
Scientific Device Laboratory, Inc.
379-B
In Commercial Distribution

  • 00810047420804 ()


  • Biological stain IVD

RAGNELL SCISSORS - 00192896075436

RAGNELL SCISSORS UNDER MINING SPATULATED CURVED BLADES POWER CUT SILVER
SONTEC INSTRUMENTS, INC.
110-318
In Commercial Distribution

  • 00192896075436 ()

  • Length: 9 Inch
110-318

  • General-purpose surgical scissors, reusable

TeleRehab Computer - 00856298006275

Computer workstation used in conjunction with TeleRehab software.
SCOTTCARE CORPORATION, THE
TeleRehab Computer
In Commercial Distribution

  • 00856298006275 ()
101819

  • Desktop computer

Integrity Computer - 00627908020130

Laptop computer for use with the first generation of the Integrity V500 system (DI: 00627908010018) and the second generation of the Integrity V500 system (DI: 00627908020017). The UDI is comprised of the following: GTIN + version/revision (VARIANT) + Date of Manufacture (PROD DATE) + Serial Number (SERIAL)
Vivosonic Inc
M500-C
In Commercial Distribution

  • 00627908020130 ()


  • Otoacoustic emission system, battery-powered
  • Evoked-potential audiometer

Tablet computer - 07640176970900

Tablet computer
Naviswiss AG
NS090
In Commercial Distribution

  • 07640176970900 ()


  • Optical surgical navigation device tracking system

Computer (Industrial) - 07290016936018

No Description
UC-CARE LTD
FPRCO00011
In Commercial Distribution

  • 07290016936018 ()
FPRCO00011

  • Rectal ultrasound navigational image processor

N/A - 00810047420156

Crypto Kinyoun Large Stain Set [250ml bottle x 3/pkg]
Scientific Device Laboratory, Inc.
379
In Commercial Distribution

  • 00810047420156 ()


  • Biological stain IVD

RIO - 00848486021702

LAPTOP COMPUTER
MAKO SURGICAL CORP.
203866
In Commercial Distribution

  • 00848486021702 ()
203866

  • Robotic surgical navigation system

N/A - 04961333241989

COMPUTER ACCESSORIES
PENTAX OF AMERICA, INC.
68403-ACC
In Commercial Distribution

  • 04961333241989 ()


  • Computer terminal

N/A - 04961333241972

COMPUTER ACCESSORIES
PENTAX OF AMERICA, INC.
68391-ACC
In Commercial Distribution

  • 04961333241972 ()


  • Computer terminal

N/A - 04961333241965

LAPTOP COMPUTER
PENTAX OF AMERICA, INC.
4307-1
In Commercial Distribution

  • 04961333241965 ()


  • Electroglottograph

IMAK RSI - 00649833201286

Computer Glove
BROWNMED, INC.
A20128
In Commercial Distribution

  • 00649833201286 ()


  • Compression/pressure glove

QUANTIEN™ - 05415067000996

Diagnostic Computer
ST. JUDE MEDICAL, INC.
Measurement System
In Commercial Distribution

  • 05415067000996 ()
C12787

  • Cardiac catheterization laboratory computer

X-GUIDE - 00817421020711

COMPUTER MOUSE
XNAV TECHNOLOGIES LLC
P008697
In Commercial Distribution

  • 00817421020711 ()
P008697

  • Surgical planning/navigation-enhancement system

ARVIS ® - 00850012315254

ARVIS Computer Module
KICO KNEE INNOVATION COMPANY PTY LIMITED
12700
In Commercial Distribution

  • 00850012315254 ()


  • Orthopaedic stereotactic surgery system

NIM-Eclipse® - 00643169438187

COMPUTER 945NWCPUE4 DESKTOP
MEDTRONIC SOFAMOR DANEK, INC.
945NWCPUE4
In Commercial Distribution

  • 00643169438187 ()


  • Nerve-locating system

N/A - 00643169438170

COMPUTER 945NCCPUE4 NOTEBOOK
MEDTRONIC SOFAMOR DANEK, INC.
945NCCPUE4
In Commercial Distribution

  • 00643169438170 ()


  • Portable computer

N/A - 00643169071957

COMPUTER 945NWCPU DESKTOP
MEDTRONIC SOFAMOR DANEK, INC.
945NWCPU
In Commercial Distribution

  • 00643169071957 ()


  • Nerve-locating system

N/A - 00643169188174

COMPUTER 945NCCPU NOTEBOOK
MEDTRONIC SOFAMOR DANEK, INC.
945NCCPU
In Commercial Distribution

  • 00643169188174 ()


  • Nerve-locating system

N/A - 04961333231102

COMPUTER, SIGNALS LAB
PENTAX OF AMERICA, INC.
7207
Not in Commercial Distribution

  • 04961333231102 ()


  • Manometric gastrointestinal motility analysis system

NIM-Eclipse® - 00613994910677

COMPUTER NCCPU NOTEBOOK
MEDTRONIC XOMED, INC.
NCCPU
In Commercial Distribution

  • 00613994910677 ()


  • Nerve-locating system

EP-4™ - 05414734219112

Touch Screen Computer
ST. JUDE MEDICAL, INC.
H21911
In Commercial Distribution

  • 05414734219112 ()
H21911

  • Cardiac electrophysiology stimulation system

Guideline 4000™ 5.0 - 00873263006757

GL5 Notebook Computer
FHC, INC.
C0216-00675
In Commercial Distribution

  • 00873263006757 ()
C0216

  • Neurophysiologic monitoring system
  • Electroencephalograph

NIM-Eclipse® - 00643169944275

COMPUTER 945NWCPUE4 DESKTOP
MEDTRONIC SOFAMOR DANEK, INC.
945NWCPUE4
In Commercial Distribution

  • 00643169944275 ()


  • Nerve-locating system

N/A - 00643169944268

COMPUTER 945NCCPUE4 LAPTOP
MEDTRONIC SOFAMOR DANEK, INC.
945NCCPUE4
In Commercial Distribution

  • 00643169944268 ()


  • Portable computer

iTero Computing Unit - 00816063020837

Scanner computer unit
Align Technology, Inc.
211385
In Commercial Distribution

  • 00816063020837 ()


  • Dental milling system, CAD/CAM, chairside

iTero Mobile Computing Unit - 00816063020844

Scanner computer unit
Align Technology, Inc.
211386
In Commercial Distribution

  • 00816063020844 ()


  • Dental milling system, CAD/CAM, chairside

Tablet computer holder - 07640176970962

Tablet computer holder
Naviswiss AG
NS096
In Commercial Distribution

  • 07640176970962 ()


  • Optical surgical navigation device tracking system

LABSYSTEM™ PRO - 08714729996934

LS10K WIN10 COMPUTER
BOSTON SCIENTIFIC CORPORATION
M00420020810
In Commercial Distribution

  • 08714729996934 ()
M00420020810

  • General-purpose multi-parameter bedside monitor

LABSYSTEM™ PRO - 08714729996927

LS10K WIN10 COMPUTER
BOSTON SCIENTIFIC CORPORATION
M0042002081D0
In Commercial Distribution

  • 08714729996927 ()
M0042002081D0

  • General-purpose multi-parameter bedside monitor

LABSYSTEM™ PRO - 08714729996910

LS10K WIN10 COMPUTER
BOSTON SCIENTIFIC CORPORATION
M0042002081H0
In Commercial Distribution

  • 08714729996910 ()
M0042002081H0

  • General-purpose multi-parameter bedside monitor

LABSYSTEM™ PRO - 08714729996903

LS10K WIN10 COMPUTER
BOSTON SCIENTIFIC CORPORATION
M0042002081R0
In Commercial Distribution

  • 08714729996903 ()
M0042002081R0

  • General-purpose multi-parameter bedside monitor

ARVIS ® - 00810180350624

ARVIS Computer Module
KICO KNEE INNOVATION COMPANY PTY LIMITED
IN-12700
In Commercial Distribution

  • 00810180350624 ()


  • Orthopaedic stereotactic surgery system

LessRay - 00887517790521

LessRay Computer Set
Nuvasive, Inc.
LRCPULOAN
In Commercial Distribution

  • 00887517790521 ()


  • Neurophysiologic monitoring system

LessRay - 00887517732699

LessRay Computer Enclosure
Nuvasive, Inc.
8230004
In Commercial Distribution

  • 00887517732699 ()


  • Diagnostic x-ray digital imaging system workstation

LessRay - 00887517948199

LessRay Computer Set
Nuvasive, Inc.
LRCPUMKT
In Commercial Distribution

  • 00887517948199 ()


  • Diagnostic x-ray digital imaging system workstation

NIM-Eclipse - 00763000384197

COMPUTER 945NWCPUE4 DESKTOP
MEDTRONIC SOFAMOR DANEK, INC.
945NWCPUE4
In Commercial Distribution

  • 00763000384197 ()


  • Nerve-locating system

NIM-Eclipse - 00763000384180

COMPUTER 945NCCPUE4 NOTEBOOK
MEDTRONIC SOFAMOR DANEK, INC.
945NCCPUE4
In Commercial Distribution

  • 00763000384180 ()


  • Portable computer

NIM-Eclipse - 00763000570262

COMPUTER 945NCCPUE4 NOTEBOOK
MEDTRONIC SOFAMOR DANEK, INC.
945NCCPUE4
In Commercial Distribution

  • 00763000570262 ()


  • Portable computer

NIM-Eclipse - 00763000570279

COMPUTER 945NWCPUE4 DESKTOP
MEDTRONIC SOFAMOR DANEK, INC.
945NWCPUE4
In Commercial Distribution

  • 00763000570279 ()


  • Nerve-locating system

NIM-ECLIPSE® - 00763000102388

COMPUTER 945NCCPUE4 LAPTOP
MEDTRONIC SOFAMOR DANEK, INC.
945NCCPUE4
In Commercial Distribution

  • 00763000102388 ()


  • Portable computer

NIM-Eclipse® - 00763000102371

COMPUTER 945NWCPUE4 DESKTOP
MEDTRONIC SOFAMOR DANEK, INC.
945NWCPUE4
In Commercial Distribution

  • 00763000102371 ()


  • Nerve-locating system

Navio - 00885556628478

Navio Computer Cart
Smith & Nephew, Inc.
PFSR110002
In Commercial Distribution

  • 00885556628478 ()
PFSR110002

  • Robotic surgical arm system

WIN10CPU UPGRADE FOR CAPTURE(INWARRANTY) - 00849832013495

WIN10 CPU UPGRADE FOR CAPTURE (IN WARRANTY)
Leica Biosystems Richmond, Inc.
23CAPWARW10CPU
Not in Commercial Distribution

  • 00849832013495 ()

  • Device Size Text, specify:


  • Desktop computer

WIN10 CPU UPGRADE FOR GSL(IN WARRANTY) - 00849832013488

WIN 10 CUP UPGRADE FOR GSL (IN WARRANTY)
Leica Biosystems Richmond, Inc.
23GSLWARW10CPU
Not in Commercial Distribution

  • 00849832013488 ()

  • Device Size Text, specify:


  • Desktop computer

Dell 6 BUTTON LASER MOUSE - 00849832013426

Dell 6 BUTTON LASER MOUSE
Leica Biosystems Richmond, Inc.
23MOS0002
Not in Commercial Distribution

  • 00849832013426 ()

  • Device Size Text, specify:


  • Desktop computer

Dell Precision 5820 - 00849832013372

Dell Precision 5820
Leica Biosystems Richmond, Inc.
23CPU1066
Not in Commercial Distribution

  • 00849832013372 ()

  • Device Size Text, specify:


  • Desktop computer

Dell Precision 3620 - 00849832013365

Dell Precision 3620
Leica Biosystems Richmond, Inc.
23CPU1065
Not in Commercial Distribution

  • 00849832013365 ()

  • Device Size Text, specify:


  • Desktop computer
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