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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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IH-Reader 24 - 07611969205486

A combination centrifuge and reader for IH gel cards
Bio-Rad Medical Diagnostics GmbH
001200
In Commercial Distribution

  • 07611969205486 ()
001200

  • Immunohaematology/blood bank analyser IVD, semi-automated

Direct Bilirubin Reagent Set - 00812137011893

For the quantitative determination of direct bilirubin in serum.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
R1 x 500mL, R2 x 15mL
In Commercial Distribution

  • 00812137011893 ()
  • 00812137012258 ()
501-402

  • Conjugated (direct) bilirubin IVD, kit, enzyme spectrophotometry

Total Bilirubin Reagent Set - 00812137011909

For the quantitative determination of total bilirubin in serum.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
R1 x 500mL, R2 x 15mL
In Commercial Distribution

  • 00812137011909 ()
  • 00812137012265 ()
501-403

  • Total bilirubin IVD, kit, enzyme spectrophotometry

Stephens Instruments - 00810799032638

Sinskey II Lens Manipulating Hook For A/C Lenses
KRISHNA IMPORTS INC
S4-1390
In Commercial Distribution

  • 00810799032638 ()
S4-1390

  • Ocular hook/spatula/manipulator, reusable

Stephens Instruments - 00810799032607

Sinskey Micro Lens Hook, 90 Degree, Angled for Shearing
KRISHNA IMPORTS INC
S4-1385
In Commercial Distribution

  • 00810799032607 ()
S4-1385

  • Ocular hook/spatula/manipulator, reusable

Custom Medical Specialties, Inc. - 00815849020283

Vinyl Acetate Urological Drainage Bag for Siemens Systems - Non-Sterile
CUSTOM ASSEMBLIES, INC.
CMS-950V
In Commercial Distribution

  • 00815849020849 ()
  • 00815849020283 ()


  • Surgical tissue/fluid collection bag, non-sterile

NA - 10887587036281

CALIBRATED TAP FOR 2.4MM CORTEX SCREWS W/HEX COUPLING
SYNTHES (U.S.A.) LP
311.242
Not in Commercial Distribution

  • H9803112420 ()
  • 10887587036281 ()
311242

  • Bone tap, single-use, non-sterile

LAZIC - 04250603711506

Aneurysm Clip Tray Stainless Steel (for 42 clips), 210x125x17mm
Peter Lazic GmbH
65.003
In Commercial Distribution

  • 04250603711506 ()
65.003

  • Instrument transport trolley system

Millennium - 00190776158026

Special Made ENT suction Tip for use with 72-SM240221CH01
Avalign Technologies, Inc.
72-SM240221CH02
In Commercial Distribution

  • 00190776158026 ()


  • B-cell acute lymphoblastic leukaemia (B-ALL) genetic mutation IVD, kit, nucleic acid technique (NAT)

Synergetics - 10841305111513

Synerfit™ Single Fiber Adapter for Bausch & Lomb Stellaris
SYNERGETICS USA, INC.
57.40
In Commercial Distribution

  • 10841305111513 ()
57.40

  • Ophthalmic light source
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