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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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Histo-Tek® - 00615233082862

Standard with Lid Detached Lilac
SAKURA FINETEK U.S.A., INC.
9343
In Commercial Distribution

  • 00615233082862 ()
9343

  • Histology tissue cassette IVD, laboratory processing, single-use

Histo-Tek® - 00615233082855

Standard with Lid Detached Green
SAKURA FINETEK U.S.A., INC.
9342
In Commercial Distribution

  • 00615233082855 ()
9342

  • Histology tissue cassette IVD, laboratory processing, single-use

Histo-Tek® - 00615233082848

Standard with Lid Detached Gray
SAKURA FINETEK U.S.A., INC.
9341
In Commercial Distribution

  • 00615233082848 ()
9341

  • Histology tissue cassette IVD, laboratory processing, single-use

Histo-Tek® - 00615233082831

Standard with Lid Detached Blue
SAKURA FINETEK U.S.A., INC.
9340
In Commercial Distribution

  • 00615233082831 ()
9340

  • Histology tissue cassette IVD, laboratory processing, single-use

MicroAire® - 00847399000736

ELECTRIC MOTOR MODULE WITH HANDSWITCH
Microaire Surgical Instruments LLC
1000ET
In Commercial Distribution

  • 00847399000736 ()


  • Surgical power tool hand-switch

Tissue-Tek® Glas™ g2 - 00615233080776

Glass Coverslipper with Barcode System
SAKURA FINETEK U.S.A., INC.
6503
In Commercial Distribution

  • 00615233080776 ()
6503

  • Barcode reader
  • Microscope slide coverslipper IVD

APOZA - 04719883751416

Ultrasonic dental scaling, with Endo.
APOZA ENTERPRISE CO., LTD.
Selector U2
In Commercial Distribution

  • 04719883751416 ()


  • Ultrasonic dental scaling/debridement system

APOZA - 04719883751393

Ultrasonic dental scaling, with Endo.
APOZA ENTERPRISE CO., LTD.
Selector U2 Plus
In Commercial Distribution

  • 04719883751393 ()


  • Ultrasonic dental scaling/debridement system

TEHLIN - 04719883460714

CHILD'S L-BRACKET, STEEL WITH EXTENSIONS
TEH LIN PROSTHETIC & ORTHOPAEDIC INC.
D-TSC-KDCS-L
In Commercial Distribution

  • 04719883460714 ()


  • External lower-limb prosthesis structural/alignment component

WatchTower - 04719876737281

Image Calibrator with Assembly Kit
INTAI TECHNOLOGY CORP.
NAVTL0001
In Commercial Distribution

  • 04719876737281 ()


  • Neurological stereotactic surgery system
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