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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Table Top Rod Cutter, 4.5-5.0-5.5-6.0 Collapsible Co Cr, Purple
TECOMET INC.
RC305008-AF
In Commercial Distribution

  • 00818069018276 ()


  • Orthopaedic implantable-device cutter
MAGNUM SALDATURA Co - Stick Ø1.7x75mm RGH - 5g - Box1 - MD
MESA DI SALA GIACOMO & C. SNC
1
In Commercial Distribution

  • 08050612203025 ()


  • Dental casting non-noble alloy
MAGNUM SALDATURA Co - Stick Ø1.7x75mm RGH - 50g - Box1 - MD
MESA DI SALA GIACOMO & C. SNC
1
In Commercial Distribution

  • 08050612202110 ()


  • Dental casting non-noble alloy
MAGNUM SALDATURA CO - Stick Ø1.7x75mm RGH - 50g - Jar1 - MD
MESA DI SALA GIACOMO & C. SNC
1
In Commercial Distribution

  • 08050612202004 ()


  • Dental casting non-noble alloy
MAGNUM SALDATURA CO - Stick Ø1.2x75mm RGH - 50g - Jar1 - MD
MESA DI SALA GIACOMO & C. SNC
1
In Commercial Distribution

  • 08050612201991 ()


  • Dental casting non-noble alloy
Co Ease Cohesive Bandage 4" x 5 yds. BLACK
Hemasource, Inc.
CE40BK
In Commercial Distribution

  • 20891153001037 ()
  • 00891153001033 ()
  • 30891153001034 ()


  • Non-adhesive device retention bandage
Acquisition unit of NExT Station
EB NEURO SPA
B9630096002
In Commercial Distribution

  • 08056446901168 ()


  • Electromyograph
  • Evoked-potential graphic recording system
Bioview® Manometry Acquisition Software
DIVERSATEK HEALTHCARE, INC.
S98-1925-7P1
In Commercial Distribution

  • 00816734022139 ()
  • B019S9819257P10 ()
S98-1925-7P1

  • Manometric gastrointestinal motility analysis system
Bioview® Manometry Acquisition Software
DIVERSATEK HEALTHCARE, INC.
S98-1925-6P1
In Commercial Distribution

  • 00816734022122 ()
  • B019S9819256P10 ()
S98-1925-6P1

  • Manometric gastrointestinal motility analysis system
Bioview® Manometry Acquisition Software
DIVERSATEK HEALTHCARE, INC.
S98-1925-5P1
In Commercial Distribution

  • 00816734022115 ()
  • B019S9819255P10 ()
S98-1925-5P1

  • Manometric gastrointestinal motility analysis system
OBM Data Acquisition Box (DAB)
XLTEK
OBM00002
In Commercial Distribution

  • 00382830010825 ()


  • Electroencephalograph
Okti 128 Channel Acquisition Module
COMPUMEDICS LIMITED
Okti 128
In Commercial Distribution

  • 09342451002228 ()
8029-0004-01

  • Electroencephalograph
  • Electroencephalographic ambulatory recorder
Okti 64 Channel Acquisition Module
COMPUMEDICS LIMITED
Okti 64
In Commercial Distribution

  • 09342451002211 ()
8029-0003-01

  • Electroencephalograph
  • Electroencephalographic ambulatory recorder
Okti 32 Channel Acquisition Module
COMPUMEDICS LIMITED
Okti 32
In Commercial Distribution

  • 09342451002204 ()
8029-0002-01

  • Electroencephalograph
  • Electroencephalographic ambulatory recorder
Dicom Box Image Acquisition Unit
HYLAND LLC
1
In Commercial Distribution

  • 00850677007037 ()


  • Radiography digital imaging scanner
Acquisition red left long cable
SAFEOP SURGICAL, INC.
EPAD
Not in Commercial Distribution

  • 00851641007084 ()
100023

  • Evoked-potential graphic recording system
Stim and Acquisition Cable Kit
ALPHATEC SPINE, INC.
100670
In Commercial Distribution

  • 00190376189116 ()


  • Electrical-only medical device connection cable, single-use
AFFIRM PRONE BIOPSY ACQUISITION WORKSTATION
Hologic, Inc.
ASY-08832
In Commercial Distribution

  • 15420045506534 ()
ASY-08832

  • Mammographic stereotactic biopsy system
Clarity® Acquisition Station (310C00)
Elekta Solutions AB
9100-00060
Not in Commercial Distribution

  • 07540180000023 ()


  • Ultrasound patient positioning system
ECG acquisition capabilities to resting ECG and stress test systems. (Wireless acquisition module)
CARDIOLINE SPA
Midmark Digital ECG
In Commercial Distribution

  • 08056732652491 ()
1-100-1550

  • Electrocardiograph, professional, multichannel
No Description
SUN NUCLEAR CORP.
468BHP
In Commercial Distribution

  • B136468BHP0 ()


  • CT phantom, test object
No Description
SUN NUCLEAR CORP.
468BH
In Commercial Distribution

  • B136468BH0 ()


  • CT phantom, test object
No Description
SUN NUCLEAR CORP.
467
In Commercial Distribution

  • B1364670 ()


  • CT phantom, test object
No Description
SUN NUCLEAR CORP.
464
In Commercial Distribution

  • B1364640 ()


  • CT phantom, test object
Catphan® 500, Complete Catphan® including housing, case, and Smári Image Analysis Database Service.
Providus Holdings, Inc.
CTP500
In Commercial Distribution

  • 00812266030024 ()


  • CT phantom, test object
COPDGene Lung Phantom ll
Providus Holdings, Inc.
CCT162
In Commercial Distribution

  • 00812266030017 ()


  • CT phantom, test object
High Resolution Module
Providus Holdings, Inc.
CTP764
In Commercial Distribution

  • 00812266031403 ()
CTP764

  • CT phantom, test object
Liver Phantom, Simplified Torso Section with Image Quality Test Inserts
Providus Holdings, Inc.
CCT288
In Commercial Distribution

  • 00812266030581 ()
CCT288

  • CT phantom, test object
Low Contrast MITA Head Phantom, MITA CT IQ Task Group Low Contrast Head Phantom
Providus Holdings, Inc.
CCT191
In Commercial Distribution

  • 00812266030574 ()
CCT191

  • CT phantom, test object
Low Contrast MITA Body Phantom, MITA CT IQ Task Group Low Contrast Body Phantom
Providus Holdings, Inc.
CCT189
In Commercial Distribution

  • 00812266030567 ()
CCT189

  • CT phantom, test object
ATCM Phantom, Automatic Tube Current Modulation Phantom
Providus Holdings, Inc.
CCT228
In Commercial Distribution

  • 00812266030550 ()
CCT228

  • CT phantom, test object
The Corgi® Phantom is a modular phantom designed for evaluation of cone beam imaging systems.
Providus Holdings, Inc.
CGI014
In Commercial Distribution

  • 00812266030529 ()
CGI014

  • CT phantom, test object
16cm OD housing and mount
Providus Holdings, Inc.
CTP541
In Commercial Distribution

  • 00812266030512 ()
CTP541

  • CT phantom, test object
Catphan® case
Providus Holdings, Inc.
CTP451
In Commercial Distribution

  • 00812266030505 ()
CTP451

  • CT phantom, test object
Catphan® 600 mount assembly
Providus Holdings, Inc.
CTP627
In Commercial Distribution

  • 00812266030499 ()
CTP627

  • CT phantom, test object
Catphan® 600 housing
Providus Holdings, Inc.
CTP623
In Commercial Distribution

  • 00812266030482 ()
CTP623

  • CT phantom, test object
30 line pair high resolution module
Providus Holdings, Inc.
CTP714
In Commercial Distribution

  • 00812266030475 ()
CTP714

  • CT phantom, test object
Geometry sensitometry and point source module
Providus Holdings, Inc.
CTP682
In Commercial Distribution

  • 00812266030468 ()
CTP682

  • CT phantom, test object
40mm bead geometry module
Providus Holdings, Inc.
CTP591
In Commercial Distribution

  • 00812266030451 ()
CTP591

  • CT phantom, test object
Subslice and supra-slice low contrast module
Providus Holdings, Inc.
CTP515
In Commercial Distribution

  • 00812266030444 ()
CTP515

  • CT phantom, test object
Solid image uniformity module
Providus Holdings, Inc.
CTP486
In Commercial Distribution

  • 00812266030437 ()
CTP486

  • CT phantom, test object
21 line pair high resolution and point source module
Providus Holdings, Inc.
CTP528
In Commercial Distribution

  • 00812266030420 ()
CTP528

  • CT phantom, test object
Slice width, sensitometry and pixel size module
Providus Holdings, Inc.
CTP404
In Commercial Distribution

  • 00812266030413 ()
CTP404

  • CT phantom, test object
Catphan® 608, Complete Catphan® including housing and case
Providus Holdings, Inc.
CTP608
In Commercial Distribution

  • 00812266030406 ()
CTP608

  • CT phantom, test object
Catphan® 606, Complete Catphan® for kVCT and MVCT including housing and case,
Providus Holdings, Inc.
CTP606
In Commercial Distribution

  • 00812266030390 ()
CTP606

  • CT phantom, test object
Catphan® 605, Compact Catphan® including housing and case
Providus Holdings, Inc.
CTP605
In Commercial Distribution

  • 00812266030383 ()
CTP605

  • CT phantom, test object
Catphan® 604, Complete Catphan® for Cone Beam CT including housing and case
Providus Holdings, Inc.
CTP604
In Commercial Distribution

  • 00812266030376 ()
CTP604

  • CT phantom, test object
Catphan® 508, Complete Catphan® including housing and case.
Providus Holdings, Inc.
CTP508
In Commercial Distribution

  • 00812266030369 ()
CTP508

  • CT phantom, test object
Catphan® 504,Complete Catphan® for Cone Beam CT including housing and case
Providus Holdings, Inc.
CTP504
In Commercial Distribution

  • 00812266030352 ()
CTP504

  • CT phantom, test object
Catphan® 503, Complete Catphan® for Cone Beam CT including housing and case
Providus Holdings, Inc.
CTP503
In Commercial Distribution

  • 00812266030345 ()
CTP503

  • CT phantom, test object
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