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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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COMPOSITE POLISHING KIT CA - E2350310B0

Contains DIs: E23501980; E23502980; E23501950; E23502950; E23501920; E23502920; E23502230; E23502280
SHOFU DENTAL CORPORATION
0310B
In Commercial Distribution

  • E2350310B0 ()
0310B

  • Dental abrasive point, reusable

ANTI-BREAST CA. AG. BCA-225 - 00810119673183

No Description
BIOGENEX LABORATORIES
AM135-5M
In Commercial Distribution

  • 00810119673183 ()

  • Total Volume: 6 Milliliter
AM135-5M

  • Breast carcinoma antigen 225 (BCA-225) IVD, antibody

Elecsys CA 15-3 II - 07613336218334

No Description
Roche Diagnostics GmbH
09755594190
In Commercial Distribution

  • 07613336218334 ()
09755594190

  • Cancer antigen 15-3 (CA15-3) IVD, kit, enzyme immunoassay (EIA)

Elecsys CA 125 II - 07613336218327

No Description
Roche Diagnostics GmbH
09755586190
In Commercial Distribution

  • 07613336218327 ()
09755586190

  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay

Globe Scientific - 00840095607780

SYSMEX: Sample Cup, 2mL, for use with Sysmex CA Series analyzers
GLOBE SCIENTIFIC INC.
5531
In Commercial Distribution

  • 00840095607780 ()
  • 00840095611756 ()
  • 00840095607797 ()
  • 00840095682473 ()


  • Assay container IVD, single-use

Curaplex - 00818834020008

TEE,VALVED,PED,15MM OD/ID,DISP,30/BX 12BX/CA
TRI-ANIM HEALTH SERVICES, INC.
301-T103
In Commercial Distribution

  • 00818834020022 ()
  • 00818834020015 ()
  • 00818834020008 ()
301-T103

  • Positive pressure airway secretion-clearing device

Na/K/Ca/pH Solution Pack - 00386100003111

Na/K/Ca/pH Solution Pack for use with EasyLyte Analyzers
MEDICA CORPORATION
2123
In Commercial Distribution

  • 00386100003111 ()
2123

  • Multiple electrolyte IVD, calibrator

Na/K/Ca/pH Solution Pack - 00386100003067

Na/K/Ca/pH Solution Pack for use with EasyLyte Analyzers
MEDICA CORPORATION
2114
In Commercial Distribution

  • 00386100003067 ()
2114

  • Multiple electrolyte IVD, calibrator

AIRPAL - 05059441185987

AirPal SPS Disposable Transfer Pad, 34 in X 78in 10/CA
Arjohuntleigh AB
AP-034SPS
In Commercial Distribution

  • 05059441185987 ()


  • Patient lifting system stretcher

AIRPAL - 05059441185932

AirPal SPS Disposable Transfer Pad, 50 in X 78in 5/CA
Arjohuntleigh AB
AP-050SPS
In Commercial Distribution

  • 05059441185932 ()


  • Patient lifting system stretcher

Maxso X92 - 00628504370629

X92, Contra Angle, 20:1 Implantology, Non-Optic, Push Button, CA Burs
Beyes Dental Canada Inc
SL3019
In Commercial Distribution

  • 00628504370629 ()


  • Dental power tool system handpiece, pneumatic

Maxso CS1-CH04 - 00628504370599

CS1-CH04, Contra Angle, 1:1, Non-Spray, Non-Optic, Latch Type, CA Burs
Beyes Dental Canada Inc
SL2028
In Commercial Distribution

  • 00628504370599 ()


  • Dental power tool system handpiece, pneumatic

Maxso CS1-CH02 - 00628504370582

CS1-CH02, Contra Angle, 1:1, Non-Spray, Non-Optic, Push Button, CA Burs
Beyes Dental Canada Inc
SL2026
In Commercial Distribution

  • 00628504370582 ()


  • Dental power tool system handpiece, pneumatic

ACE - 00614950020812

BONE TAP CA F/3.3 ST IMPLANT 36TL MARKINGS: 8-18MM (TI6AL4VELI)
ACE SURGICAL SUPPLY CO., INC.
04956101
In Commercial Distribution

  • 00614950020812 ()

  • Outer Diameter: 3.3 Millimeter
04956101

  • Bone tap, reusable

ACE - 00614950012817

BUR KIRSCHNER CA 34TL 15CL TAPER 1.6 TO 2.35MM INT IRRIG
ACE SURGICAL SUPPLY CO., INC.
88330009
In Commercial Distribution

  • 00614950012817 ()

  • Outer Diameter: 2.1 Millimeter
88330009

  • Steel dental bur, reusable

ACE - 00614950012145

TWO PIECE TREPHINE CA SHANK W/DEPTH STOP TI 6AL 4VELI
ACE SURGICAL SUPPLY CO., INC.
04941001
In Commercial Distribution

  • 00614950012145 ()
04941001

  • Steel dental bur, reusable

ACE - 00614950011827

BUR TREPHINE 35TL 4.25ID 5.1OD 18.5CL CA MRKS 8-10-13-15-18TI INTERNAL IRRIGATION
ACE SURGICAL SUPPLY CO., INC.
04948202
In Commercial Distribution

  • 00614950011827 ()

  • Outer Diameter: 5.1 Millimeter
04948202

  • Titanium dental bur

ACE - 00614950011810

BUR TREPHINE 35TL 3.75ID 4.6OD 18.5CL CA MRKS 8-10-13-15-18TI INTERNAL IRRIGATION
ACE SURGICAL SUPPLY CO., INC.
04948201
In Commercial Distribution

  • 00614950011810 ()

  • Outer Diameter: 4.6 Millimeter
04948201

  • Titanium dental bur

ACE - 00614950011803

BUR TREPHINE 35TL 2.75ID 3.5OD 18.5CL CA MRKS 8-10-13-15-18TI INTERNAL IRRIGATION
ACE SURGICAL SUPPLY CO., INC.
04948002
In Commercial Distribution

  • 00614950011803 ()

  • Outer Diameter: 3.5 Millimeter
04948002

  • Titanium dental bur

ACE - 00614950011674

BUR TREPHINE 35TL 4.25ID 5.1OD 18.5CL CA MRKS 8-10-13-15-18TI INTERNAL IRRIGATION
ACE SURGICAL SUPPLY CO., INC.
04948202
In Commercial Distribution

  • 00614950011674 ()

  • Outer Diameter: 5.1 Millimeter
04948202

  • Titanium dental bur

ACE - 00614950011667

BUR TREPHINE 35TL 3.75ID 4.6OD 18.5CL CA MRKS 8-10-13-15-18TI INTERNAL IRRIGATION
ACE SURGICAL SUPPLY CO., INC.
04948201
In Commercial Distribution

  • 00614950011667 ()

  • Outer Diameter: 4.6 Millimeter
04948201

  • Titanium dental bur

ACE - 00614950011650

BUR TREPHINE 35TL 2.75ID 3.5OD 18.5CL CA MRKS 8-10-13-15-18TI INTERNAL IRRIGATION
ACE SURGICAL SUPPLY CO., INC.
04948002
In Commercial Distribution

  • 00614950011650 ()

  • Outer Diameter: 3.5 Millimeter
04948002

  • Titanium dental bur

ACE - 00614950010677

4.35MM FLAT BOTTOM CA 11.5CL 30TL II SHORT SS/TI NITRIDE
ACE SURGICAL SUPPLY CO., INC.
04968701
In Commercial Distribution

  • 00614950010677 ()
04968701

  • Fluted surgical drill bit, reusable

ACE - 00614950010646

3.3MM TWIST DRILL CA 30TL SS MARKINGS:8,10,11.5MM NO INTERNAL IRRIGATION
ACE SURGICAL SUPPLY CO., INC.
04968102
In Commercial Distribution

  • 00614950010646 ()
04968102

  • Fluted surgical drill bit, reusable

ACE - 00614950010639

2.8MM TWIST DRILL CA 30TL SS MARKING:8,10,11.5MM NO INTERNAL IRRIGATION
ACE SURGICAL SUPPLY CO., INC.
04968101
In Commercial Distribution

  • 00614950010639 ()
04968101

  • Fluted surgical drill bit, reusable

ACE - 00614950010486

3.3HD TWIST DRILL CA 37TL SS MARKINGS:8,10,11.5,13,15 NO INTERNAL IRRIGATION
ACE SURGICAL SUPPLY CO., INC.
04958102
In Commercial Distribution

  • 00614950010486 ()
04958102

  • Fluted surgical drill bit, reusable

ACE - 00614950008810

ACE EXTENSION TUBE 30" STER 4CC VOLUME L/F 100/CA
ACE SURGICAL SUPPLY CO., INC.
0030030
In Commercial Distribution

  • 10614950008817 ()
  • 00614950008810 ()

  • Total Volume: 4 Milliliter
  • Length: 30 Inch
0030030

  • Intravenous administration tubing extension set

ACE - 00614950008803

ACE EXTENSION TUBE 20" STER 3CC VOLUME L/F 100/CA
ACE SURGICAL SUPPLY CO., INC.
0030020
In Commercial Distribution

  • 10614950008800 ()
  • 00614950008803 ()

  • Total Volume: 3 Milliliter
  • Length: 20 Inch
0030020

  • Intravenous administration tubing extension set

ACE - 00614950008797

ACE EXTENSION TUBE 12" STER 2CC VOLUME L/F 100/CA
ACE SURGICAL SUPPLY CO., INC.
0030012
In Commercial Distribution

  • 10614950008794 ()
  • 00614950008797 ()

  • Length: 12 Inch
  • Total Volume: 2 Milliliter
0030012

  • Intravenous administration tubing extension set

FOGARTY SAFEJAW - 00690103043914

SPRING CLIP,DBL SAFEJAW 6MM FOGARTY,LTX FREE,STER,10/CA
Edwards Lifesciences LLC
CDSAFE6
In Commercial Distribution

  • 00690103043914 ()
  • 70690103043913 ()

  • MAXIMUM JAW OPENING: 6MM
CDSAFE6

  • Vascular clamp, single-use

iCE Surgical Light - 00684706009279

S1 400DT Dual CA 1000 850 2x 3p Dual yoke SL-30M
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706009279 ()
C14D3233

  • Operating room light

iCE Surgical Light - 00684706007985

Series 1 300 DT Single CA 1000mm 3p dual yoke SL-30M
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706007985 ()
C13S33

  • Operating room light

iCE Surgical Light - 00684706007404

Series 1 300 DT Single CA 850mm Gen 2 sgl Monitor
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706007404 ()
C13S21

  • Operating room light

iCE Surgical Light - 00684706007213

S1 400DT Dual CA 1000 850 2x 3p Dual yoke SL-30M
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706007213 ()
C14D3233

  • Operating room light

iCE Surgical Light - 00684706007107

Series 1 300DT 1150/1000 CA 4K Camera 30M Monitor holder
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706007107 ()
C13D43S1

  • Operating room light

iCE Surgical Light - 00684706007060

S3 300DT sgl/dual/sgl CA 1300,1150,1000,1300 2xG2 sgl MH 2xSL-30M
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706007060 ()
C33SDS54351331

  • Operating room light

iCE Surgical Light - 00684706007022

S1 200 DT 1150 850 CA LCH 3P SL-30M Sgl MH
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706007022 ()
C12D4241

  • Operating room light

iCE Surgical Light - 00684706006988

S1 200DT 1000mm 850mm CA DY 9P 30M DY 3P 30M
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706006988 ()
C12D3253

  • Operating room light

iCE Surgical Light - 00684706006612

Series 1 200 DT Single CA 1300mm Gen 1 Dual Monitor
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706006612 ()
C12S52

  • Operating room light

iCE Surgical Light - 00684706006605

Series 1 200 DT Single CA 1300mm Gen 2 sgl Monitor
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706006605 ()
C12S51

  • Operating room light

iCE Surgical Light - 00684706006483

S1 700DT Dual CA 1150 1000 3P SL-30M Sgl MH Barco
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706006483 ()
C17D433K

  • Operating room light

iCE Surgical Light - 00684706006254

Series 1 200 DT Single CA 1000mm Single MH Sony monitor
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706006254 ()
C12S3M

  • Operating room light

iCE Surgical Light - 00684706003758

S1 400DT 1000 850 CA 3P DY SL-30M 9P DY SL-30M
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706003758 ()
C14D3235

  • Operating room light

iCE Surgical Light - 00684706003574

Series 1 300 DT Single CA 1450mm Gen 2 sgl Monitor
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706003574 ()
C13S61

  • Operating room light

iCE Surgical Light - 00684706003338

S3 300DT Sgl CA 850mm Sgl MH for Barco conv/integration
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706003338 ()
C33BSB2L

  • Operating room light

iCE Surgical Light - 00684706003321

S1 300DT Dual CA 1000 850 2x 3p Dual yoke SL-30M
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706003321 ()
C13D3233

  • Operating room light

iCE Surgical Light - 00684706003260

Series 1 300 DT Single CA 700mm Gen 2 sgl Monitor
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706003260 ()
C13S11

  • Operating room light

iCE Surgical Light - 00684706003116

Series 1 300 DT Single CA 1750mm 3p dual yoke SL-30M
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706003116 ()
C13S83

  • Operating room light

iCE Surgical Light - 00684706003109

Series 1 300 DT Single CA 2250mm 3p dual yoke SL-30M
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706003109 ()
C13S93

  • Operating room light

iCE Surgical Light - 00684706003093

Series 1 200DT Sngl CA 1150 dual yok 3P SL-30M MH
Amico Clinical Solutions Corp
iCE30m
In Commercial Distribution

  • 00684706003093 ()
C12D4341

  • Operating room light
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