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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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Persona® Trabecular Metal® - 00889024561526

No Description
Zimmer, Inc.
42-5562-031-10
In Commercial Distribution

  • 00889024561526 ()

  • Size CD, 10 mm, Thickness
42-5562-031-10

  • Knee arthroplasty wedge

Persona® - 00889024245730

No Description
Zimmer, Inc.
42-5279-002-04
In Commercial Distribution

  • 00889024245730 ()

  • Size CD 14 mm Thickness
42-5279-002-04

  • Knee tibia prosthesis trial, reusable

PERSONA™ - 00889024245723

No Description
Zimmer, Inc.
42-5279-002-03
In Commercial Distribution

  • 00889024245723 ()

  • Size CD, 13 mm Thickness
42-5279-002-03

  • Knee tibia prosthesis trial, reusable

Persona® - 00889024245716

No Description
Zimmer, Inc.
42-5279-002-02
In Commercial Distribution

  • 00889024245716 ()

  • Size CD 12 mm Thickness
42-5279-002-02

  • Knee tibia prosthesis trial, reusable

PERSONA™ - 00889024245709

No Description
Zimmer, Inc.
42-5279-002-01
In Commercial Distribution

  • 00889024245709 ()

  • Size CD, 11 mm Thickness
42-5279-002-01

  • Knee tibia prosthesis trial, reusable

Persona® - 00889024245693

No Description
Zimmer, Inc.
42-5279-002-00
In Commercial Distribution

  • 00889024245693 ()

  • Size CD 10 mm Thickness
42-5279-002-00

  • Knee tibia prosthesis trial, reusable

Welch Allyn, Inc. - 00732094263985

HScribe Review Workstation - version 6 for HScribe review, edit, and signing capabilities. Includes current software CD and user manual CD; Software kit; Australia power cord; No printer
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094263985 ()
HSCRIBWS-6AC-BXXXX

  • Electrocardiographic long-term ambulatory recording analyser application software

BioPlex 2200 - 00847865012973

APLS IgG, IgM and IgA Assay Protocol File CD, SW4.1_v1 US Only
BIO-RAD LABORATORIES, INC.
SW4.1V1
In Commercial Distribution

  • 00847865012973 ()

  • 1 Each
6651975B

  • Phospholipid antibody IVD, kit, multiplex

Durelon™ - 04035077004879

3M™ ESPE™ Durelon™ CD Carboxylate Luting Cement Triple Pack, 38235
3M Deutschland GmbH
38235
In Commercial Distribution

  • 04035077004879 ()
38235

  • Zinc polycarboxylate dental cement

Durelon™ - J001702011360020

3M™ ESPE™ Durelon™ CD Carboxylate Luting Cement Triple Pack, 38235
3M Deutschland GmbH
38235
In Commercial Distribution

  • J001702011360020 ()
38235

  • Zinc polycarboxylate dental cement
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