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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

M SERIES - 00847946005252

Defibrillator ,MAIN, BASIC-3 SPO2/12LEAD AC/EL/RC/SM/CD
Zoll Medical Corporation
40021211000003010
In Commercial Distribution

  • 00847946005252 ()

  • 6.8" x 10.3" x 8.2"


  • Rechargeable professional automated external defibrillator

M SERIES - 00847946002992

Defibrillator ,MAIN,BASIC-3,3/5LEAD,DC,EL,RC,SM,CD, ENG
Zoll Medical Corporation
40010021000003010
In Commercial Distribution

  • 00847946002992 ()

  • 6.8" x 10.3" x 8.2"


  • Rechargeable professional automated external defibrillator

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

NA - 07630031733672

CD Ø 1.65 Core Drill, left-hand cut, for Service Set
Institut Straumann AG
non-surgically Invasive Instruments
In Commercial Distribution

  • 07630031733672 ()

  • Outer Diameter: 1.65 Millimeter
046.757

  • Dental implant internal thread shaping tool

NA - 07630031733665

CD Ø 1.45 Core Drill, left-hand cut, for Service Set
Institut Straumann AG
non-surgically Invasive Instruments
In Commercial Distribution

  • 07630031733665 ()

  • Outer Diameter: 1.45 Millimeter
046.756

  • Dental implant internal thread shaping tool

NA - 07630031733122

CD Ø 1.3 Core Drill, left-hand cut, for Service Set
Institut Straumann AG
non-surgically Invasive Instruments
In Commercial Distribution

  • 07630031733122 ()

  • Outer Diameter: 1.3 Millimeter
026.0127

  • Dental implant internal thread shaping tool

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 - 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

Persona Total Knee System - 00889024488779

No Description
Zimmer, Inc.
82-0156-880-06
In Commercial Distribution

  • 00889024488779 ()

  • CR Provisional, Size 10, C-D, Right
82-0156-880-06

  • Knee tibia prosthesis trial, reusable

Persona Total Knee System - 00889024488762

No Description
Zimmer, Inc.
82-0156-880-05
In Commercial Distribution

  • 00889024488762 ()

  • CR Provisional, Size 16, C-D, Left
82-0156-880-05

  • Knee tibia prosthesis trial, reusable

Persona Total Knee System - 00889024488755

No Description
Zimmer, Inc.
82-0156-880-04
In Commercial Distribution

  • 00889024488755 ()

  • CR Provisional, Size 14, C-D, Left
82-0156-880-04

  • Knee tibia prosthesis trial, reusable

Persona Total Knee System - 00889024488748

No Description
Zimmer, Inc.
82-0156-880-03
In Commercial Distribution

  • 00889024488748 ()

  • CR Provisional, Size 13, C-D, Left
82-0156-880-03

  • Knee tibia prosthesis trial, reusable

Persona Total Knee System - 00889024488731

No Description
Zimmer, Inc.
82-0156-880-02
In Commercial Distribution

  • 00889024488731 ()

  • CR Provisional, Size 12, C-D, Left
82-0156-880-02

  • Knee tibia prosthesis trial, reusable

Persona Total Knee System - 00889024488724

No Description
Zimmer, Inc.
82-0156-880-01
In Commercial Distribution

  • 00889024488724 ()

  • CR Provisional, Size 11, C-D, Left
82-0156-880-01

  • Knee tibia prosthesis trial, reusable

Persona Total Knee System - 00889024488717

No Description
Zimmer, Inc.
82-0156-880-00
In Commercial Distribution

  • 00889024488717 ()

  • CR Provisional, Size 10, C-D, Left
82-0156-880-00

  • Knee tibia prosthesis trial, reusable

VOLMED BRASIL - 07908783000589

MINI CANNULA FOR AGGRESSIVE INCISOR MICRODEBIDEMENT 4,5-115-15°CD-SJ
VOLMED BRASIL EQUIPAMENTOS LTDA
2742.CD.1103-P
In Commercial Distribution

  • 07908783000589 ()


  • Arthroscopic shaver system blade, single-use

VOLMED BRASIL - 07908783000572

MINI CANNULA FOR AGGRESSIVE INCISOR MICRODEBIDEMENT 4,5-115-12°CD-RZM
VOLMED BRASIL EQUIPAMENTOS LTDA
2742.CD.1102-O
In Commercial Distribution

  • 07908783000572 ()


  • Arthroscopic shaver system blade, single-use
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