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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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BioPlex 2200 - 03610520138267

BioPlex 2200 Syphilis Total & RPR Assay Protocol File CD SW4.3_v1
BIO-RAD LABORATORIES, INC.
4.3_v1
In Commercial Distribution

  • 03610520138267 ()

  • 1 Each
12000657

  • Treponema pallidum reagin antibody IVD, reagent
  • Treponema pallidum total antibody IVD, kit, fluorescent immunoassay

CD - 06976289698013

No Description
Changzhou Care-de Sanitary Material Co.,Ltd.
21”*225 ft
In Commercial Distribution

  • 06976289698013 ()


  • Examination/treatment table paper

CD - 06976289697016

No Description
Changzhou Care-de Sanitary Material Co.,Ltd.
42”*30”
In Commercial Distribution

  • 06976289697016 ()


  • Patient gown, single-use

CD - 06976289696019

No Description
Changzhou Care-de Sanitary Material Co.,Ltd.
23”*36”
In Commercial Distribution

  • 06976289696019 ()


  • Absorbent underpad, non-antimicrobial, single-use

CD - 06976289695012

No Description
Changzhou Care-de Sanitary Material Co.,Ltd.
33*45cm
In Commercial Distribution

  • 06976289695012 ()


  • Dental bib

Vasomedical™ EZ™ Software CD and Data Cable for Wrist Pulse Oximeter - 00817980021440

EZ™ Software CD and Data Cable for Wrist Pulse Oximeter
VASOMEDICAL, INC.
Model EZ
In Commercial Distribution

  • 00817980021440 ()
A13-0041

  • Pulse oximeter

M SERIES - 00847946003609

Defibrillator ,MAIN BSC-4 BIPH/SPO2/AC/PC/EL/RC/SM/CD
Zoll Medical Corporation
40010211100103010
In Commercial Distribution

  • 00847946003609 ()

  • 6.8" x 10.3" x 8.2"


  • Rechargeable professional automated external defibrillator

Welch Allyn, Inc. - 00732094263978

HScribe Server - version 6, current software CD; Software kit; No connectivity
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094263978 ()
HSERV-6AA-XXXXX

  • Electrocardiographic long-term ambulatory recording analyser application software

Welch Allyn, Inc. - 00732094308440

Q-Stress Server - version 6, current software CD; Software kit; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094308440 ()
QSERV-6AA-XXXXX

  • Electrocardiographic lead set, reusable

Persona Total Knee System - 00889024488601

No Description
Zimmer, Inc.
82-0156-858-61
In Commercial Distribution

  • 00889024488601 ()

  • CR Provisional, 3-9/ C-D, Left
  • Height: 9 Millimeter
82-0156-858-61

  • Knee tibia prosthesis trial, reusable

Persona Total Knee System - 00889024488625

No Description
Zimmer, Inc.
82-0156-858-63
In Commercial Distribution

  • 00889024488625 ()

  • CR Provisional, 3-9/ C-D, Right
  • Height: 9 Millimeter
82-0156-858-63

  • Knee tibia prosthesis trial, reusable

Persona Total Knee System - 00889024488618

No Description
Zimmer, Inc.
82-0156-858-62
In Commercial Distribution

  • 00889024488618 ()

  • Height: 8 Millimeter
  • CR Provisional, 3-9/ C-D, Right
82-0156-858-62

  • Knee tibia prosthesis trial, reusable

Persona Total Knee System - 00889024488595

No Description
Zimmer, Inc.
82-0156-858-60
In Commercial Distribution

  • 00889024488595 ()

  • Height: 8 Millimeter
  • CR Provisional, 3-9/ C-D, Left
82-0156-858-60

  • Knee tibia prosthesis trial, reusable

Persona® Knee System - 00889024630413

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

  • 00889024630413 ()

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

  • Knee tibia prosthesis trial, reusable

Persona® Knee System - 00889024630406

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

  • 00889024630406 ()

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

  • Knee tibia prosthesis trial, reusable

Persona® Knee System - 00889024630390

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

  • 00889024630390 ()

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

  • Knee tibia prosthesis trial, reusable

Persona® - 00889024557543

No Description
Zimmer, Inc.
42-5558-034-15
In Commercial Distribution

  • 00889024557543 ()

  • Size CD, 15 mm, Thickness
42-5558-034-15

  • Knee arthroplasty wedge

Persona® - 00889024557536

No Description
Zimmer, Inc.
42-5558-033-15
In Commercial Distribution

  • 00889024557536 ()

  • Size CD, 15 mm, Thickness
42-5558-033-15

  • Knee arthroplasty wedge

Persona® - 00889024557529

No Description
Zimmer, Inc.
42-5558-032-15
In Commercial Distribution

  • 00889024557529 ()

  • Size CD, 15 mm, Thickness
42-5558-032-15

  • Knee arthroplasty wedge

Persona® - 00889024557512

No Description
Zimmer, Inc.
42-5558-031-15
In Commercial Distribution

  • 00889024557512 ()

  • Size CD, 15 mm, Thickness
42-5558-031-15

  • Knee arthroplasty wedge

Persona® - 00889024557345

No Description
Zimmer, Inc.
42-5558-033-10
In Commercial Distribution

  • 00889024557345 ()

  • Size CD, 10 mm, Thickness
42-5558-033-10

  • Knee arthroplasty wedge

Persona® - 00889024557338

No Description
Zimmer, Inc.
42-5558-032-10
In Commercial Distribution

  • 00889024557338 ()

  • Size CD, 10 mm, Thickness
42-5558-032-10

  • Knee arthroplasty wedge

Persona® - 00889024557352

No Description
Zimmer, Inc.
42-5558-034-10
In Commercial Distribution

  • 00889024557352 ()

  • Size CD, 10 mm, Thickness
42-5558-034-10

  • Knee arthroplasty wedge

Persona® - 00889024557321

No Description
Zimmer, Inc.
42-5558-031-10
In Commercial Distribution

  • 00889024557321 ()

  • Size CD, 10 mm, Thickness
42-5558-031-10

  • Knee arthroplasty wedge

Persona® - 00889024557154

No Description
Zimmer, Inc.
42-5558-034-05
In Commercial Distribution

  • 00889024557154 ()

  • Size CD, 5 mm, Thickness
42-5558-034-05

  • Knee arthroplasty wedge

Persona® - 00889024557147

No Description
Zimmer, Inc.
42-5558-033-05
In Commercial Distribution

  • 00889024557147 ()

  • Size CD, 5 mm, Thickness
42-5558-033-05

  • Knee arthroplasty wedge

Persona® - 00889024557130

No Description
Zimmer, Inc.
42-5558-032-05
In Commercial Distribution

  • 00889024557130 ()

  • Size CD, 5 mm, Thickness
42-5558-032-05

  • Knee arthroplasty wedge

Persona® - 00889024557123

No Description
Zimmer, Inc.
42-5558-031-05
In Commercial Distribution

  • 00889024557123 ()

  • Size CD, 5 mm, Thickness
42-5558-031-05

  • Knee arthroplasty wedge

Persona® Trabecular Metal® - 00889024561755

No Description
Zimmer, Inc.
42-5562-034-15
In Commercial Distribution

  • 00889024561755 ()

  • Size CD, 15 mm, Thickness
42-5562-034-15

  • Knee arthroplasty wedge

Persona® Trabecular Metal® - 00889024561731

No Description
Zimmer, Inc.
42-5562-032-15
In Commercial Distribution

  • 00889024561731 ()

  • Size CD, 15 mm, Thickness
42-5562-032-15

  • Knee arthroplasty wedge

Persona® Trabecular Metal® - 00889024561533

No Description
Zimmer, Inc.
42-5562-032-10
In Commercial Distribution

  • 00889024561533 ()

  • Size CD, 10 mm, Thickness
42-5562-032-10

  • Knee arthroplasty wedge

Persona® Trabecular Metal® - 00889024561359

No Description
Zimmer, Inc.
42-5562-034-05
In Commercial Distribution

  • 00889024561359 ()

  • Size CD, 5 mm, Thickness
42-5562-034-05

  • Knee arthroplasty wedge

Persona® Trabecular Metal® - 00889024561342

No Description
Zimmer, Inc.
42-5562-033-05
In Commercial Distribution

  • 00889024561342 ()

  • Size CD, 5 mm, Thickness
42-5562-033-05

  • Knee arthroplasty wedge

Persona® Trabecular Metal® - 00889024561335

No Description
Zimmer, Inc.
42-5562-032-05
In Commercial Distribution

  • 00889024561335 ()

  • Size CD, 5 mm, Thickness
42-5562-032-05

  • Knee arthroplasty wedge

Persona® Trabecular Metal® - 00889024561328

No Description
Zimmer, Inc.
42-5562-031-05
In Commercial Distribution

  • 00889024561328 ()

  • Size CD, 5 mm, Thickness
42-5562-031-05

  • Knee arthroplasty wedge

Persona® Trabecular Metal® - 00889024561748

No Description
Zimmer, Inc.
42-5562-033-15
In Commercial Distribution

  • 00889024561748 ()

  • Size CD, 15 mm, Thickness
42-5562-033-15

  • Knee arthroplasty wedge

Persona® Trabecular Metal® - 00889024561724

No Description
Zimmer, Inc.
42-5562-031-15
In Commercial Distribution

  • 00889024561724 ()

  • Size CD, 15 mm, Thickness
42-5562-031-15

  • Knee arthroplasty wedge

Persona® Trabecular Metal® - 00889024561557

No Description
Zimmer, Inc.
42-5562-034-10
In Commercial Distribution

  • 00889024561557 ()

  • Size CD, 10 mm, Thickness
42-5562-034-10

  • Knee arthroplasty wedge

Persona® Trabecular Metal® - 00889024561540

No Description
Zimmer, Inc.
42-5562-033-10
In Commercial Distribution

  • 00889024561540 ()

  • Size CD, 10 mm, Thickness
42-5562-033-10

  • Knee arthroplasty wedge

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
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