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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ZILMASTER FINE CA CUP 3PCS
SHOFU DENTAL CORPORATION
0673
In Commercial Distribution

  • E23506730 ()
0673

  • Dental abrasive point, reusable
ZILMASTER FINE CA KNIFE 3PCS
SHOFU DENTAL CORPORATION
0672
In Commercial Distribution

  • E23506720 ()
0672

  • Dental abrasive point, reusable
ZILMASTER FINE CA BULLET 3PCS
SHOFU DENTAL CORPORATION
0670
In Commercial Distribution

  • E23506700 ()
0670

  • Dental abrasive point, reusable
ZILMASTER MEDIUM CA ASSORT 4PC
SHOFU DENTAL CORPORATION
0669
In Commercial Distribution

  • E23506690 ()
0669

  • Dental abrasive point, reusable
ZILMASTER MEDIUM CA CUP 3PCS
SHOFU DENTAL CORPORATION
0668
In Commercial Distribution

  • E23506680 ()
0668

  • Dental abrasive point, reusable
ZILMASTER MEDIUM CA MINI POINT
SHOFU DENTAL CORPORATION
0666
In Commercial Distribution

  • E23506660 ()
0666

  • Dental abrasive point, reusable
ZILMASTER MEDIUM CA BULLET 3PC
SHOFU DENTAL CORPORATION
0665
In Commercial Distribution

  • E23506650 ()
0665

  • Dental abrasive point, reusable
ZILMASTER COARSE CA ASSORT 4PC
SHOFU DENTAL CORPORATION
0664
In Commercial Distribution

  • E23506640 ()
0664

  • Dental abrasive point, reusable
ZILMASTER COARSE CA CUP 3PCS
SHOFU DENTAL CORPORATION
0663
In Commercial Distribution

  • E23506630 ()
0663

  • Dental abrasive point, reusable
ZILMASTER COARSE CA KNIFE 3PCS
SHOFU DENTAL CORPORATION
0662
In Commercial Distribution

  • E23506620 ()
0662

  • Dental abrasive point, reusable
ZILMASTER MEDIUM CA KNIFE 3PCS
SHOFU DENTAL CORPORATION
0659
In Commercial Distribution

  • E23506590 ()
0659

  • Dental abrasive point, reusable
ZILMASTER COARSE CA BULLET 3PC
SHOFU DENTAL CORPORATION
0658
In Commercial Distribution

  • E23506580 ()
0658

  • Dental abrasive point, reusable
SUPER SNAP MINI KIT CA
SHOFU DENTAL CORPORATION
0505
In Commercial Distribution

  • E23505050 ()
0505

  • Dental abrasive disk, reusable
SHOFU Composite Finishing Kit CA
SHOFU DENTAL CORPORATION
0306
In Commercial Distribution

  • E23503060 ()
0306

  • Dental abrasive point, reusable
VITROS Chemistry Products Ca Slides
ORTHO-CLINICAL DIAGNOSTICS, INC.
1450261
In Commercial Distribution

  • 10758750009114 ()
  • 20758750009111 ()
1450261

  • Calcium (Ca2+) IVD, reagent
CA NORTHSTATE D1 OPERATIVE 1P
Peter Brasseler Holdings, LLC
5029946U0
In Commercial Distribution

  • 00887919944379 ()


  • Diamond dental bur, single-use
PIPS CA DRESSING CHANGE TRAY
Cardinal Health 200, LLC
03F2276B
In Commercial Distribution

  • 50197106388431 ()
  • 10197106388433 ()
03F2276B

  • General surgical procedure kit, medicated
HUB CD320 CMDR FLEX - CA
Medtronic Care Management Services, LLC
101001-002
In Commercial Distribution

  • 00763000286989 ()


  • Multiple physiological parameter spot-check system, home-use
HBSS, NO CA, NO MG
DIAGNOSTIC HYBRIDS, INC.
10-120500
In Commercial Distribution

  • 30014613331124 ()
10-120500

  • Cell culture medium IVD
HBSS, NO CA, NO MG
DIAGNOSTIC HYBRIDS, INC.
10-120100
In Commercial Distribution

  • 30014613331117 ()
10-120100

  • Cell culture medium IVD
PIPS CA IV START TRAY
Cardinal Health 200, LLC
01C2276A
In Commercial Distribution

  • 50197106327126 ()
  • 10197106327128 ()
01C2276A

  • Vascular catheterization support/maintenance kit, non-medicated
PIPS CA DRESSING CHANGE TRAY
Cardinal Health 200, LLC
03F2276A
In Commercial Distribution

  • 50197106326945 ()
  • 10197106326947 ()
03F2276A

  • General surgical procedure kit, medicated
PRO TECHNOLOGY PUMP - US/CA
JOERNS HEALTHCARE, LLC
PMP-CU-01
In Commercial Distribution

  • 00810055880430 ()


  • Alternating-pressure bed mattress overlay system
Menu CA Cutoff +50%, 50mL
BIOCHEMICAL DIAGNOSTICS INC
18008464
In Commercial Distribution

  • 00810042683358 ()
18008464

  • Multiple drugs of abuse IVD, control
Menu CA Cutoff -50%, 50mL
BIOCHEMICAL DIAGNOSTICS INC
18008463
In Commercial Distribution

  • 00810042683334 ()
18008463

  • Multiple drugs of abuse IVD, control
Gs/Gw Drive-Lock CA Short
INTRA-LOCK INTERNATIONAL, INC.
SDLCAS
In Commercial Distribution

  • D742SDLCAS0 ()
SDLCAS

  • Dental implant system
KaVo NOMAD Pro 2, CA
Dental Imaging Technologies Corporation
1.013.7788
Not in Commercial Distribution

  • EKAV101377880 ()


  • Diagnostic x-ray system generator, hand-held
5R200 Mirror Magic 100/ca
DEROYAL INDUSTRIES, INC.
28-ZIRC
In Commercial Distribution

  • 50749756851928 ()
  • 00749756851923 ()


  • Endoscope antifog solution
S3 300 DT 2xSgl CA 1xDual CA 1150,1000,850,1150, 2x Sgl MH, 2x LCH SL-30M
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706001785 ()
C33SDS43241441

  • Operating room light
S3 300 DT sgl CA dual CA 1300 1150 1000 3x 9p DY SL-3M
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706001068 ()
C33SDB543555

  • Operating room light
Series 3 400DT sgl CA dual CA 1300,1150,1000 DUAL YOK 30M 30M MH1(G2)
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706000979 ()
C34SDB543733

  • Operating room light
AccuThrive Vitality Microtome Blade Low Profile SS Microcoat 500BL/CA (50BL/DISP 10DISP/CA)
AccuTec, Inc.
Microtome Blade
In Commercial Distribution

  • 10843382104297 ()
  • 00843382104290 ()
AVBL-2023-0000

  • Microtome blade IVD, single-use
AccuThrive Vitality Microtome Blade Low Profile SS Microcoat 100BL/CA (10BL/DISP 10DISP/CA)
AccuTec, Inc.
Microtome Blade
In Commercial Distribution

  • 10843382104280 ()
  • 00843382104283 ()
AVBL-2022-0000

  • Microtome blade IVD, single-use
AccuThrive Vitality Microtome Blade High Profile SS Microcoat 500BL/CA (50BL/DISP 10DISP/CA)
AccuTec, Inc.
Microtome Blade
In Commercial Distribution

  • 10843382104082 ()
  • 00843382104085 ()
AVBL-2021-0000

  • Microtome blade IVD, single-use
AccuThrive Vitality Microtome Blade High Profile SS Microcoat 100BL/CA (10BL/DISP 10DISP/CA)
AccuTec, Inc.
Microtome Blade
In Commercial Distribution

  • 10843382104075 ()
  • 00843382104078 ()
AVBL-2020-0000

  • Microtome blade IVD, single-use
AccuThrive Longevity Microtome Blade Low Profile SS Microcoat 500BL/CA (50BL/DISP 10DISP/CA)
AccuTec, Inc.
Microtome Blade
In Commercial Distribution

  • 10843382104068 ()
  • 00843382104061 ()
AVBL-2011-0000

  • Microtome blade IVD, single-use
AccuThrive Longevity Microtome Blade High Profile Microcoat 500BL/CA (50BL/DISP 10 DISP/CA)
AccuTec, Inc.
Microtome Blade
In Commercial Distribution

  • 10843382104044 ()
  • 00843382104047 ()
AVBL-2009-0000

  • Microtome blade IVD, single-use
AccuThrive Longevity Microtome Blade High Profile SS Microcoat, 100BL/CA (10BL/DISP 10DISP/CA)
AccuTec, Inc.
Microtome Blade
In Commercial Distribution

  • 10843382104037 ()
  • 00843382104030 ()
AVBL-2008-0000

  • Microtome blade IVD, single-use
AccuThrive Agility Microtome Blade High Profile SS Microcoat 100BL/CA (10BL/DISP 10DISP/CA)
AccuTec, Inc.
Microtome Blade
In Commercial Distribution

  • 10843382103979 ()
  • 00843382103972 ()
AVBL-2004-0000

  • Microtome blade IVD, single-use
S3 300DT 2x Sgl CA 1xdual CA 2x 1150, 1x1000,1x850, 2xsgl MH 1x3P 1x9P SL-30M
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706001914 ()
C33SDS43241351

  • Operating room light
S3 400DT 2x Sgl CA 1xdual CA 2x 1150, 1x1000,1x850, 2xsgl MH 1x3P 1x9P SL-30M
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706001587 ()
C34SDS43241351

  • Operating room light
S3 300 DT Sgl CA Dual CA 1300 1150 1000 9P DY 30M 2xMH Gen2
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706001082 ()
C33SDB543151

  • Operating room light
S3 300 DT Sgl CA Dual CA 1300 1150 1000 3P DY 30M 2xMH Gen2
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706001075 ()
C33SDB543131

  • Operating room light
S1 200DT Triple CA 1300 1150 1000 CA 2x LCH 3P SL-30M, 1x Sgl MH
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706007091 ()
C12T543441

  • Operating room light
AccuThrive Longevity Microtome Blade Low Profile SS Microcoat 100BL/CA (10BL/DISP, 10 DISP/CA)
AccuTec, Inc.
Microtome Blade
In Commercial Distribution

  • 10843382104051 ()
  • 00843382104054 ()
AVBL-2010-0000

  • Microtome blade IVD, single-use
AccuThrive Agility Microtome Blade Low Profile SS Microcoat 100BL/CA (10BL/DISP 10 DISP/CA)
AccuTec, Inc.
Microtome Blade
In Commercial Distribution

  • 10843382104020 ()
  • 00843382104023 ()
AVBL-2006-0000

  • Microtome blade IVD, single-use
AccuThrive Agility Microtome Blade High Profile SS Microcoat 500BL/CA (50BL/DISP 10 DISP/CA)
AccuTec, Inc.
Microtome Blade
In Commercial Distribution

  • 10843382104013 ()
  • 00843382104016 ()
AVBL-2005-0000

  • Microtome blade IVD, single-use
AccuThrive Agility Microtome Blade Low Profile SS Microcoat 500BL/CA (50BL/DISP 10 DISP/CA)
AccuTec, Inc.
Microtome Blade
In Commercial Distribution

  • 10843382104006 ()
  • 00843382104009 ()
AVBL-2007-0000

  • Microtome blade IVD, single-use
PROVIDENCE CA D&C/GYN PACK
MEDLINE INDUSTRIES, INC.
DYNJ35091C
In Commercial Distribution

  • 10889942320707 ()
DYNJ35091C

  • General surgical procedure kit, non-medicated, reusable
E733 Ca electrode for ABL7XX/8XX
Radiometer Medical ApS
945-616
In Commercial Distribution

  • 05700699456168 ()
945-616

  • Calcium (Ca2+) IVD, kit, ion-selective electrode (ISE)
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