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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 - 00847865012508

APLS IgG, IgM and IgA Assay Protocol File CD, SW4_v1
BIO-RAD LABORATORIES, INC.
SW4_1
In Commercial Distribution

  • 00847865012508 ()

  • 1 Each
6651975A

  • Phospholipid antibody IVD, kit, multiplex

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. - 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 - 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

Persona Total Knee System - 00889024488786

No Description
Zimmer, Inc.
82-0156-880-07
In Commercial Distribution

  • 00889024488786 ()

  • CR Provisional, Size 11, C-D, Right
82-0156-880-07

  • Knee tibia prosthesis trial, reusable
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