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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 - 03610520519813

BioPlex® 2200 HIV Ag-Ab Assay Protocol Files CD SW4.2_v4
BIO-RAD LABORATORIES, INC.
SW4.2_v4
In Commercial Distribution

  • 03610520519813 ()

  • 1 Each
6653475A

  • Laboratory instrument/analyser application software IVD

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

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

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 Total Knee System - 00889024488823

No Description
Zimmer, Inc.
82-0156-880-11
In Commercial Distribution

  • 00889024488823 ()

  • CR Provisional, Size 16, C-D, Right
82-0156-880-11

  • Knee tibia prosthesis trial, reusable

Persona Total Knee System - 00889024488816

No Description
Zimmer, Inc.
82-0156-880-10
In Commercial Distribution

  • 00889024488816 ()

  • CR Provisional, Size 14, C-D, Right
82-0156-880-10

  • Knee tibia prosthesis trial, reusable

Persona Total Knee System - 00889024488809

No Description
Zimmer, Inc.
82-0156-880-09
In Commercial Distribution

  • 00889024488809 ()

  • CR Provisional, Size 13, C-D, Right
82-0156-880-09

  • Knee tibia prosthesis trial, reusable

Persona Total Knee System - 00889024488793

No Description
Zimmer, Inc.
82-0156-880-08
In Commercial Distribution

  • 00889024488793 ()

  • CR Provisional, Size 12, C-D, Right
82-0156-880-08

  • Knee tibia prosthesis trial, reusable
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