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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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VOLMED BRASIL - 07908783000145

MINI CANNULA FOR AGGRESSIVE INCISOR MICRODEBIDEMENT 3,5-115-15-15°CD-SJ
VOLMED BRASIL EQUIPAMENTOS LTDA
2739.CD.1103-P
In Commercial Distribution

  • 07908783000145 ()


  • Arthroscopic shaver system blade, single-use

Miele - 04002515648643

Washer-Disinfector
Miele & Cie. KG
PG 8582 CD
In Commercial Distribution

  • 04002515648643 ()


  • Surgical utensil washer/disinfector

Welch Allyn, Inc. - 00732094263985

HScribe Review Workstation - version 6 for HScribe review, edit, and signing capabilities. Includes current software CD and user manual CD; Software kit; Australia power cord; No printer
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094263985 ()
HSCRIBWS-6AC-BXXXX

  • Electrocardiographic long-term ambulatory recording analyser application software

BioPlex 2200 - 00847865012973

APLS IgG, IgM and IgA Assay Protocol File CD, SW4.1_v1 US Only
BIO-RAD LABORATORIES, INC.
SW4.1V1
In Commercial Distribution

  • 00847865012973 ()

  • 1 Each
6651975B

  • Phospholipid antibody IVD, kit, multiplex

M SERIES - 00847946012281

Defibrillator ,MAIN ASSY,BASIC-3,3/5LEAD,AC,EL,RC,SM,CD,ENG REFURB
Zoll Medical Corporation
60010011000003010
In Commercial Distribution

  • 00847946012281 ()

  • 6.8" x 10.3" x 8.2"


  • Rechargeable professional automated external defibrillator

CRW® - 10381780252610

StereoCalc 2.0 Software
INTEGRA LIFESCIENCES CORPORATION
SCSWCD
Not in Commercial Distribution

  • M248SCSWCD1 ()
  • 10381780252610 ()
SC SW CD

  • Neurological stereotactic surgery system

Durelon™ - J001702011360020

3M™ ESPE™ Durelon™ CD Carboxylate Luting Cement Triple Pack, 38235
3M Deutschland GmbH
38235
In Commercial Distribution

  • J001702011360020 ()
38235

  • Zinc polycarboxylate dental cement

M SERIES - 00847946003531

Defibrillator ,MAIN ASSY BSC-4, 3/5 LEAD AC/PACE/LCD/RCDR/SMRY/CD
Zoll Medical Corporation
40010011000100010
In Commercial Distribution

  • 00847946003531 ()

  • 6.8" x 10.3" x 8.2"


  • Rechargeable professional automated external defibrillator

M SERIES - 00847946012953

Defibrillator ,MAIN ASSY,BASIC-4,3/5LEAD,AC,PACE,LCD,RCDR,SMRY,CD,ENG, REFURB
Zoll Medical Corporation
60010011000100010
In Commercial Distribution

  • 00847946012953 ()

  • 6.8" x 10.3" x 8.2"


  • Rechargeable professional automated external defibrillator

Durelon™ - 04035077004879

3M™ ESPE™ Durelon™ CD Carboxylate Luting Cement Triple Pack, 38235
3M Deutschland GmbH
38235
In Commercial Distribution

  • 04035077004879 ()
38235

  • Zinc polycarboxylate dental cement
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