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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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Persona® The Personalized Knee System - 00889024204829

No Description
Zimmer, Inc.
00-5908-015-20
In Commercial Distribution

  • 00889024204829 ()

  • Size C-D
00-5908-015-20

  • Device sterilization/disinfection container, reusable

Persona® The Personalized Knee System - 00889024204430

No Description
Zimmer, Inc.
00-5907-082-46
In Commercial Distribution

  • 00889024204430 ()

  • Right CD
00-5907-082-46

  • Device sterilization/disinfection container, reusable

Persona® The Personalized Knee System - 00889024202504

No Description
Zimmer, Inc.
00-5907-015-20
In Commercial Distribution

  • 00889024202504 ()

  • Size C-D
00-5907-015-20

  • Device sterilization/disinfection container, reusable

MICRO-MILL® NexGen® - 00889024216662

No Description
Zimmer, Inc.
5978-07-03
Not in Commercial Distribution

  • 00889024216662 ()

  • Sizes C-D


  • Orthopaedic prosthesis implantation positioning instrument, reusable

NexGen® - 00889024216693

No Description
Zimmer, Inc.
5978-07-13
In Commercial Distribution

  • 00889024216693 ()

  • Size C-D
00-5978-007-13

  • Orthopaedic prosthesis implantation positioning instrument, reusable

PERSONA® - 00889024247321

No Description
Zimmer, Inc.
42-5399-022-03
In Commercial Distribution

  • 00889024247321 ()

  • Size C-D
42-5399-022-03

  • Orthopaedic prosthesis implantation positioning instrument, reusable

ADULT LIMB RECONSTRUCTION SYSTEM - 18033509858093

PLASTIC NUT FOR CD WITH CLICKER AND CD GARCHES (PACK OF 5 OF EACH)
ORTHOFIX SRL
1
In Commercial Distribution

  • 18033509858093 ()
950086M

  • External orthopaedic fixation system, reusable

Fisher & Paykel Healthcare - 09420012424266

F&P InfoUSB
FISHER & PAYKEL HEALTHCARE LIMITED
900ICON203
In Commercial Distribution

  • 09420012429100 ()
  • 09420012424266 ()
900ICON203

  • Digital storage media

Fisher & Paykel Healthcare - 09420012423115

F&P InfoUSB
FISHER & PAYKEL HEALTHCARE LIMITED
900ICON202
In Commercial Distribution

  • 09420012427854 ()
  • 09420012423115 ()
900ICON202

  • Digital storage media

Fisher & Paykel Healthcare - 09420012421524

SMARTSTICK-5 PACK HC254
FISHER & PAYKEL HEALTHCARE LIMITED
900HC611
In Commercial Distribution

  • 09420012421524 ()
900HC611

  • Digital storage media

Leica Biosystems RDX QUICKSTOR 8863 USB3 - 00849832013235

Leica Biosystems RDX QUICKSTOR 8863 USB3
Leica Biosystems Richmond, Inc.
23RDX8863
Not in Commercial Distribution

  • 00849832013235 ()

  • Device Size Text, specify:


  • Digital storage media

Leica Biosystems CytoVision Removable Archive Device - 00849832005155

Leica Biosystems Cytovision Removable Archive Device
Leica Biosystems Richmond, Inc.
23STR003XXX001
Not in Commercial Distribution

  • 00849832005155 ()

  • Device Size Text, specify:


  • Digital storage media

N/A - 04961333242184

MEDICAP USB 300
PENTAX OF AMERICA, INC.
9139HD
In Commercial Distribution

  • 04961333242184 ()


  • Digital storage media

N/A - 04961333241835

KEYBOARD, SUPER MINI USB
PENTAX OF AMERICA, INC.
1111-1871
In Commercial Distribution

  • 04961333241835 ()


  • Digital storage media

N/A - 04961333240654

MEDICAP USB200 DIGITAL REC
PENTAX OF AMERICA, INC.
9139
In Commercial Distribution

  • 04961333240654 ()


  • Digital storage media

PORTABLE MEMORY - 04953170304965

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-1925
Not in Commercial Distribution

  • 04953170304965 ()


  • Digital storage media

DMC-EZ - 00850018049139

DICOM Media Creator - USB Thermal
Storage Solutions Technology Group Inc.
DMC-EZ USB
In Commercial Distribution

  • 00850018049139 ()
DMC-EZ USB

  • DICOM image data disc-recording unit

DMC-EZ - 00850018049122

DICOM Media Creator - 575 Inkjet
Storage Solutions Technology Group Inc.
DMC-EZ 575
In Commercial Distribution

  • 00850018049122 ()
DMC-EZ 575

  • DICOM image data disc-recording unit

DMC-EZ - 00850018049054

DICOM Media Creator - FLUP
Storage Solutions Technology Group Inc.
DMC-EZ FLUP
In Commercial Distribution

  • 00850018049054 ()
DMC-EZ FLUP

  • DICOM image data disc-recording unit

DMC-EZ - 00850018049047

DICOM Media Creator - 8500 Thermal
Storage Solutions Technology Group Inc.
DMC-EZ 8500
In Commercial Distribution

  • 00850018049047 ()
DMC-EZ 8500

  • DICOM image data disc-recording unit

DMC-EZ - 00850018049030

DICOM Media Creator - 3600 Thermal
Storage Solutions Technology Group Inc.
DMC-EZ 3600
In Commercial Distribution

  • 00850018049030 ()
DMC-EZ 3600

  • DICOM image data disc-recording unit

DMC-EZ - 00850018049023

DICOM Media Creator - 250 Inkjet
Storage Solutions Technology Group Inc.
DMC-EZ 250
In Commercial Distribution

  • 00850018049023 ()
DMC-EZ 250

  • DICOM image data disc-recording unit

DMC-EZ - 00850018049016

DICOM Media Creator - 55 Inkjet
Storage Solutions Technology Group Inc.
DMC-EZ 55
In Commercial Distribution

  • 00850018049016 ()
DMC-EZ 55

  • DICOM image data disc-recording unit

DMC-EZ - 00850018049009

DICOM Media Creator - 25 Inkjet
Storage Solutions Technology Group Inc.
DMC-EZ 25
In Commercial Distribution

  • 00850018049009 ()
DMC-EZ 25

  • DICOM image data disc-recording unit

N'Vision® - 00643169425545

CABLE 8580 DATA IR FOR 8840 WIN8 GLOBAL
MEDTRONIC, INC.
8580
In Commercial Distribution

  • 00643169425545 ()


  • Digital storage media

Data Logger Bravo (T) - 07540196002394

Data logger for Bravo Chamber Autoclave
Scican Ltd
01-111730
In Commercial Distribution

  • 07540196002394 ()
01-111730

  • Digital storage media

Data Logger Bravo (G) - 07540196002387

Data logger for Bravo Chamber Autoclave
Scican Ltd
01-111729
In Commercial Distribution

  • 07540196002387 ()
01-111729

  • Digital storage media

Data Logger Statim/Hydrim - 07540196000963

Data logger for Statim Cassette Autoclaves and Hydrim Instrument Washers
Scican Ltd
01-111770
In Commercial Distribution

  • 07540196000963 ()
01-111770

  • Digital storage media

Codonics Virtua® C Controller - 92C - 00814905020427

Virtua C/E DICOM Server/Publisher Controller -92C
CODONICS INC.
Virtua C -92C
In Commercial Distribution

  • 00814905020427 ()


  • DICOM image data disc-recording unit

Codonics Virtua® XR Controller - 76C - 00814905020410

Virtua XR DICOM Server/Publisher Controller -76C
CODONICS INC.
Virtua XR - 76C
In Commercial Distribution

  • 00814905020410 ()


  • DICOM image data disc-recording unit

Codonics Virtua® XR Controller - 72C - 00814905020403

Virtua XR DICOM Server/Publisher Controller -72C
CODONICS INC.
Virtua XR - 72C
In Commercial Distribution

  • 00814905020403 ()


  • DICOM image data disc-recording unit

Codonics Virtua® Controller - 75C - 00814905020397

Virtua DICOM Server/Publisher Controller -75C
CODONICS INC.
Virtua -75C
In Commercial Distribution

  • 00814905020397 ()


  • DICOM image data disc-recording unit

Codonics Virtua® Controller - 71C - 00814905020380

Virtua DICOM Server/Publisher Controller -71C
CODONICS INC.
Virtua -71C
In Commercial Distribution

  • 00814905020380 ()


  • DICOM image data disc-recording unit

Codonics Virtua® C/E Medical Disc Publisher - 00814905020359

Integrated Virtua C/E DICOM Server & Medical Disc (CD/DVD) Publisher System
CODONICS INC.
Virtua C/E
In Commercial Distribution

  • 00814905020359 ()


  • DICOM image data disc-recording unit

Codonics Virtua® C Controller - 90C - 00814905020342

Virtua C DICOM Server/Publisher Controller -90C
CODONICS INC.
Virtua C -90C
In Commercial Distribution

  • 00814905020342 ()


  • DICOM image data disc-recording unit

Codonics Virtua® XR Medical Disc Publisher - 00814905020335

Integrated Virtua XR DICOM Server & Medical Disc (CD/DVD) Publisher System
CODONICS INC.
Virtua XR
In Commercial Distribution

  • 00814905020335 ()


  • DICOM image data disc-recording unit

Codonics Virtua® Medical Disc Publisher - 00814905020328

Integrated Virtua DICOM Server & Medical Disc (CD/DVD) Publisher System
CODONICS INC.
Virtua
In Commercial Distribution

  • 00814905020328 ()


  • DICOM image data disc-recording unit

Codonics Virtua® C Controller - 91C - 00814905020311

Virtua E/C DICOM Server/Publisher Controller -91C
CODONICS INC.
Virtua C -91C
In Commercial Distribution

  • 00814905020311 ()


  • DICOM image data disc-recording unit

Codonics Virtua® XR Controller - 74C - 00814905020304

Virtua XR DICOM Server/Publisher Controller -74C Device Level
CODONICS INC.
Virtua XR - 74C
In Commercial Distribution

  • 00814905020304 ()


  • DICOM image data disc-recording unit

Codonics Virtua® Controller - 73C - 00814905020298

Virtua DICOM Server/Publisher Controller -73C
CODONICS INC.
Virtua - 73C
In Commercial Distribution

  • 00814905020298 ()


  • DICOM image data disc-recording unit
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