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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 - 03610521185987

BioPlex 2200 25-OH Vitamin D Assay Protocol File CD SW4.3_v5
BIO-RAD LABORATORIES, INC.
4.3_v5
In Commercial Distribution

  • 03610521185987 ()

  • 1 Each
12006557

  • Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay

Sherlock - 00801741124396

SHERLOCK 3CG FOR SR6 USB UPGRADE KIT W/ IFU CD
Bard Access Systems, Inc.
9770137
In Commercial Distribution

  • 00801741124396 ()
9770137

  • Central venous catheter navigation system, electrocardiographic/magnetic

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

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

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

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

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

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® - 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® - 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® - 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® - 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® - 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® 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
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