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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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CAPI 3 PROTEINE 6 - 03607360025031

PROTEIN SEPARATION USING CAPILLARYS 3
SEBIA
2503
In Commercial Distribution

  • 03607360025031 ()
2503

  • Protein electrophoresis IVD, kit, electrophoresis

MINICAP CDT MAXI KIT - 03607360022283

CARBOHYDRATE DEF TRANSFERRIN BY CE MINICAP
SEBIA
2228
In Commercial Distribution

  • 03607360022283 ()
2228

  • Transferrin/transferrin isoform IVD, kit, electrophoresis

CAPILLARYS 3 WASH SOLUTION (1) - 03607360020623

CAPILLARYS 3 WASH SOLUTION IS USED IN CONJUNCTION WITH 510K CLEARED KITS. THE SOLUTION WAS PART OF THE PERFORMANCE TESTING INCLUDED WITH K161928.
SEBIA
2062
In Commercial Distribution

  • 03607360020623 ()
2062

  • Wash/cleaning solution IVD, automated/semi-automated system

BD Blunt Filter NRFit - 00382904000660

BD® Blunt Filter NRFit™ Needle, 18G x 1 1/2 in
BECTON, DICKINSON AND COMPANY
400066
In Commercial Distribution

  • 30382904000661 ()
  • 00382904000660 ()
  • 50382904000665 ()

  • Length: 40 Millimeter
  • Needle Gauge: 18 Gauge
400066

  • Medication transfer needle, non-filtering/non-vented
  • Medication transfer straw

Power Dental USA - D9431979N2

POWER IMPLANT GUIDE NEW EXTENTION KIT WITH MEASUREMENTS PARALLELING GUIDE WITH BOX
Power Dental U.S.A. Inc.
1979N2
In Commercial Distribution

  • D9431979N2 ()
1979N2

  • Dressing/utility forceps, scissors-like, reusable
  • General-purpose calliper, metallic

ACM - 04546540899071

Bowl with High Vacuum Blades and Cement Cartridge with Breakaway Femoral Nozzle
STRYKER CORPORATION
0306564000
In Commercial Distribution

  • 34546540899072 ()
  • 04546540899071 ()

  • Weight: 180.0 Gram
0306564000

  • Manual orthopaedic cement mixer, reusable

Speedlock - 00848657004749

Speedlock Needle Holder, 5mm, tapered jaw with TC inserts, 26cm with Ratchet
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
8516-00-26-R
In Commercial Distribution

  • 00848657004749 ()


  • Suturing needle holder, reusable

Power Dental USA - D943N1979N2

POWER IMPLANT GUIDE NEW EXTENTION KIT WITH MEASUREMENTS PARALLELING GUIDE WITH BOX
Power Dental U.S.A. Inc.
N1979N2
In Commercial Distribution

  • D943N1979N2 ()
N1979N2

  • General-purpose calliper, metallic

Batrik Bitestrong Bite Blocks - 00690521000148

Bitestrong Bite Blocks with Nasal Oxygen Delivery, 18 mm, Reusable, with strap
Batrik Medical Manufacturing Inc
BO2-R
In Commercial Distribution

  • 00690521000148 ()
BO2-R

  • Endoscopic bite block, basic, single-use

DELFIA Wash Concentrate - 06438147149865

For use with the DELFIA® Platewash after dilution with deionized water.
Wallac Oy
4010-0010
In Commercial Distribution

  • 06438147149865 ()
4010-0010

  • Buffered wash solution IVD
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