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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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ITD - 00840178700759

Classic Cart eco W500 40U RAL 7035/3003
Touchpoint Medical, Inc.
CD 00019.4
In Commercial Distribution

  • 00840178700759 ()


  • Electromechanical device/system transport trolley

ITD - 00840178700742

Uni Cart /5 37U RAL 7035/7035
Touchpoint Medical, Inc.
CD 00018.4
In Commercial Distribution

  • 00840178700742 ()


  • Electromechanical device/system transport trolley

ITD - 00840178700018

Uni-Cart 24U/ 4 Castors Versajet II
Touchpoint Medical, Inc.
CD.00166.800
In Commercial Distribution

  • 00840178700018 ()


  • Electromechanical device/system transport trolley

IVA Cage - 08809557207885

Cervical Disc Prep Tray
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809557207885 ()
CD.1000

  • General internal orthopaedic fixation system implantation kit

Counter Sink Drill - 07290109741161

Countersink Drill 5.0X6.0
BHI IMPLANTS LTD
1
In Commercial Distribution

  • 07290109741161 ()
CD 5.0X6.0

  • Fixture/appliance dental drill bit, reusable

Counter Sink Drill - 07290109741154

Countersink Drill 3.75X4.20
BHI IMPLANTS LTD
1
In Commercial Distribution

  • 07290109741154 ()
CD 3.75X4.20

  • Fixture/appliance dental drill bit, reusable

Medtronic Reusable Instruments - 00673978062389

INSTRUMENT 85626 CD RED PED PRCSS ELVTR
MEDTRONIC SOFAMOR DANEK, INC.
85626
In Commercial Distribution

  • 00673978062389 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

Medtronic Reusable Instruments - 00673978062372

INSTRUMENT 85621 CD RED TRNS PRCSS ELVTR
MEDTRONIC SOFAMOR DANEK, INC.
85621
In Commercial Distribution

  • 00673978062372 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

Medtronic Reusable Instruments - 00673978062297

INSTRUMENT 85601 CD STRAIGHT RED HK HLDR
MEDTRONIC SOFAMOR DANEK, INC.
85601
In Commercial Distribution

  • 00673978062297 ()


  • General-purpose surgical scissors, reusable

Medtronic Reusable Instruments - 00673978058238

INSTRUMENT 84659 CD ILIO SAC SCRWDR CAN
MEDTRONIC SOFAMOR DANEK, INC.
84659
In Commercial Distribution

  • 00673978058238 ()


  • Orthopaedic implant driver

CUSTOM SOUND SUITE 4.0 - CD VERSION - ENGLISH - 09321502029599

CUSTOM SOUND SUITE 4.0 - CD VERSION - ENGLISH
COCHLEAR LIMITED
Z361240
In Commercial Distribution

  • 09321502029599 ()
Z361240

  • Audiometric/hearing device software

CUSTOM SOUND SUITE 4.1 SP3 (US) - CD - 09321502029452

CUSTOM SOUND SUITE 4.1 SP3 (US) - CD
COCHLEAR LIMITED
Z540369
In Commercial Distribution

  • 09321502029452 ()
Z540369

  • Audiometric/hearing device software

syngo Dynamics - 04056869227047

syngo Dynamics VA20F Workplace Installer CD Label
Siemens Healthcare GmbH
10745438
In Commercial Distribution

  • 04056869227047 ()


  • Radiological PACS software

BioPlex 2200 - 00847865010580

Celiac IgA Assay Protocol File CD, SW4_v1
BIO-RAD LABORATORIES, INC.
SW4_v1
In Commercial Distribution

  • 00847865010580 ()

  • 1 Each
6652370A

  • Multiple Coeliac disease-associated antibody IVD, kit, multiplex

HIGH DEFINITION LCD MONITOR - 04953170363498

"OEV-262H HIGH DEFINITION LED L CD MONITO"
OLYMPUS MEDICAL SYSTEMS CORP.
OEV262H
In Commercial Distribution

  • 04953170363498 ()


  • Image display unit, colour

BioPlex 2200 - 00847865010993

HSV-1 & HSV-2 Assay Protocol File CD, SW4.1_v2
BIO-RAD LABORATORIES, INC.
SW4.1_V2
In Commercial Distribution

  • 00847865010993 ()

  • 1 Each
6653370E

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

BioPlex 2200 - 00847865010979

MMRV IgG Assay Protocol File CD, SW4.1_v1
BIO-RAD LABORATORIES, INC.
SW4.1_V1
In Commercial Distribution

  • 00847865010979 ()

  • 1 Each
6652470D

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Mumps virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Measles virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

BioPlex 2200 - 00847865010962

Celiac IgG Assay Protocol File CD, SW4.1_v1
BIO-RAD LABORATORIES, INC.
SW4.1v1
In Commercial Distribution

  • 00847865010962 ()

  • 1 Each
6652270B

  • Multiple Coeliac disease-associated antibody IVD, kit, multiplex

BioPlex 2200 - 00847865010948

ToRC IgG Assay Protocol File CD, SW4.1_v1
BIO-RAD LABORATORIES, INC.
SW4.1_V1
In Commercial Distribution

  • 00847865010948 ()

  • 1 Each
6651670H

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

BioPlex 2200 - 00847865010924

Syphilis IgG Assay Protocol File CD, SW4.1_v1
BIO-RAD LABORATORIES, INC.
SW4.1_v1
In Commercial Distribution

  • 00847865010924 ()

  • 1 Each
6651470E

  • Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay
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