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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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Fisher & Paykel Healthcare - 09420012423115

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

  • 09420012427854 ()
  • 09420012423115 ()
900ICON202

  • Digital storage media

N/A - 04961333240654

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

  • 04961333240654 ()


  • 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

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

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 - 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 - 71C - 00814905020380

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

  • 00814905020380 ()


  • 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® 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® Controller - 73C - 00814905020298

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

  • 00814905020298 ()


  • 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® 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® 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® 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® 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

CareLink - 00763000253325

KIT MMT-7306 USB CARELINK 2.4 RF INSERT
MEDTRONIC MINIMED, INC.
MMT-7306
In Commercial Distribution

  • 00763000253325 ()


  • Digital storage media

Durelon™ - J001702011003620

3M™ ESPE™ Durelon™ CD Carboxylate Luting Cement Liquid CD Triple Pack, 38267
3M Deutschland GmbH
38267
In Commercial Distribution

  • J001702011003620 ()
  • J001702011003624 ()
38267

  • Zinc polycarboxylate dental cement

HU-FRIEDY - 10889950046071

NUB62 BURNISHER/CD NORTHWESTERN #6 HDL
HU-FRIEDY MFG. CO., LLC
CV7180
Not in Commercial Distribution

  • 10889950046071 ()
CV7180

  • Manual dental burnisher, reusable

HU-FRIEDY - 10889950045647

DE CD CVA1/WACD, Satin Steel
HU-FRIEDY MFG. CO., LLC
CV5411
Not in Commercial Distribution

  • 10889950045647 ()
CV5411

  • Dental restoration carver, amalgam, reusable

HU-FRIEDY - 10889950042745

W-A-C-D CD#6 Hdl Carver, Amalgam
HU-FRIEDY MFG. CO., LLC
CDWACD6
Not in Commercial Distribution

  • 10889950042745 ()
CDWACD6

  • Dental restoration carver, amalgam, reusable

BioPlex 2200 - 00847865010955

Vasculitis Assay Protocol File CD, SW4.1_v1
BIO-RAD LABORATORIES, INC.
SW4.1 V1
In Commercial Distribution

  • 00847865010955 ()

  • 1 Each
6651870E

  • Multiple vasculitis-associated antibody IVD, kit, multiplex

BioPlex 2200 - 00847865002394

Vasculitis Assay Protocol File CD, SW4_v2
BIO-RAD LABORATORIES, INC.
SW4 V2
In Commercial Distribution

  • 00847865002394 ()

  • 1 Each
6651870D

  • Multiple vasculitis-associated antibody IVD, kit, multiplex

BioPlex 2200 - 00847865002288

Anti-CCP Assay Protocol File CD, SW4_v3
BIO-RAD LABORATORIES, INC.
SW4_V3
In Commercial Distribution

  • 00847865002288 ()

  • 1 Each
6653270D

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, multiplex

BioPlex 2200 - 00847865000826

CD, BioPlex Anti-CCP Calibrator Lot Data
BIO-RAD LABORATORIES, INC.
6633220
In Commercial Distribution

  • 00847865000826 ()

  • 1 Each
6633220

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, calibrator

Accuguide® - 00613994161635

SOFTWARE 8263005 ACCUGUIDE MONIT V2.0 CD
MEDTRONIC XOMED, INC.
8263005
In Commercial Distribution

  • 00613994161635 ()


  • Nerve-locating system

WAVESCAN OFFLINE PROGRAMMING MODULE - 05050474591905

INSTALL CD,WS 3.68,OPM,US
JOHNSON & JOHNSON SURGICAL VISION, INC.
0070-2533
Not in Commercial Distribution

  • 05050474591905 ()
0070-2533

  • Laser application software

MEDI - 00636257025932

PROFILE ARM OVERSLEEVE NO GAUNTLET C-D
MEDI MANUFACTURING, INC.
CFAMSCV3
In Commercial Distribution

  • 00636257025932 ()


  • Compression bandaging kit

NA - 00721902378102

TUBING 3046R1 6PK CD W/RECEPTASEAL
MEDTRONIC, INC.
3046R1
Not in Commercial Distribution

  • 20721902378106 ()
  • 00721902378102 ()


  • Cardiopulmonary bypass system blood tubing set

N/A - 00673978062310

INSTRUMENT 85603 CD 5MM ROD GRIPPER
MEDTRONIC SOFAMOR DANEK, INC.
85603
In Commercial Distribution

  • 00673978062310 ()


  • Bone-screw internal spinal fixation system rod

N/A - 00673978057996

INSTRUMENT 84626 CD PED PROC ELEVATOR
MEDTRONIC SOFAMOR DANEK, INC.
84626
In Commercial Distribution

  • 00673978057996 ()


  • Bone lever/elevator, reusable

N/A - 00673978057965

INSTRUMENT 84621 CD TRANS PROC ELEVATOR
MEDTRONIC SOFAMOR DANEK, INC.
84621
In Commercial Distribution

  • 00673978057965 ()


  • Bone lever/elevator, reusable

N/A - 00673978011394

CASE 185-064 CD HORIZON BASELID STEAM
MEDTRONIC SOFAMOR DANEK, INC.
185-064
In Commercial Distribution

  • 00673978011394 ()


  • Instrument tray, reusable

Medline Industries, Inc. - 10889942916603

TAPE MEDI-STRIP 1/8X3IN 5/CD
MEDLINE INDUSTRIES, INC.
DYNJZ29756
In Commercial Distribution

  • 40889942916604 ()
  • 10889942916603 ()
DYNJZ29756

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10889942916580

TAPE MEDI-STRIP 1/4X3IN 3/CD
MEDLINE INDUSTRIES, INC.
DYNJZ29751
In Commercial Distribution

  • 40889942916581 ()
  • 10889942916580 ()
DYNJZ29751

  • General surgical procedure kit, non-medicated, single-use

Medline Industries, Inc. - 10889942916573

TAPE MEDI-STRIP 1/4X1.5IN 6/CD
MEDLINE INDUSTRIES, INC.
DYNJZ29748
In Commercial Distribution

  • 40889942916574 ()
  • 10889942916573 ()
DYNJZ29748

  • General surgical procedure kit, non-medicated, single-use
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