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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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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
CA 15-3, Clone DBMM1, 10ml
Slmp, LLC
(BTO) CA 15-3 (DBMM1) Antibody (10ml)
In Commercial Distribution

  • 00810170550522 ()
MM12-10

  • Cancer antigen 15-3 (CA15-3) IVD, antibody
PRO TECHNOLOGY PUMP - US/CA
JOERNS HEALTHCARE, LLC
PMP-CU-01
In Commercial Distribution

  • 00810055880430 ()


  • Alternating-pressure bed mattress overlay system
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
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
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
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
1066 MADSEN Astera 2, CA Only
Natus Medical Denmark ApS
8-04-13102-CA
In Commercial Distribution

  • 05713315009204 ()
8-04-13102-CA

  • Speech audiometer
PROVIDENCE CA D&C/GYN PACK
MEDLINE INDUSTRIES, INC.
DYNJ35091F
In Commercial Distribution

  • 10889942937783 ()
  • 40889942937784 ()
DYNJ35091F

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