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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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Brasseler USA - 00887919852483

A638BLUE CD BOUCHARD AND JUTRAS
Peter Brasseler Holdings, LLC
5027668U0
In Commercial Distribution

  • 00887919852483 ()


  • Diamond dental bur, single-use

Brasseler USA - 00887919846444

A631RED CD J.P. BOUFFORD 1P
Peter Brasseler Holdings, LLC
5027518U0
In Commercial Distribution

  • 00887919846444 ()


  • Diamond dental bur, single-use

Brasseler USA - 00887919846413

A635PURPLE CD J.P. BOUFFORD 1P
Peter Brasseler Holdings, LLC
5027517U0
In Commercial Distribution

  • 00887919846413 ()


  • Diamond dental bur, single-use

Brasseler USA - 00887919831259

A600BLUE CD BLANCHETTE ET INC
Peter Brasseler Holdings, LLC
5027261U0
In Commercial Distribution

  • 00887919831259 ()


  • Diamond dental bur, single-use

Brasseler USA - 00887919828556

A637BLACK CD MAIZERETS INC 1P
Peter Brasseler Holdings, LLC
5027217U0
In Commercial Distribution

  • 00887919828556 ()


  • Diamond dental bur, single-use

Brasseler USA - 00887919877332

A637BLACK CD MAIZERETS INC 1P
Peter Brasseler Holdings, LLC
5028362U0
In Commercial Distribution

  • 00887919877332 ()


  • Diamond dental bur, single-use

Brasseler USA - 00887919864042

A600BLK CD DUPUIS & LACOMBE 1P
Peter Brasseler Holdings, LLC
5027974U0
In Commercial Distribution

  • 00887919864042 ()


  • Diamond dental bur, single-use

Brasseler USA - 00887919864011

A600PURP CD DUPUIS & LACOMBE 1P
Peter Brasseler Holdings, LLC
5027973U0
In Commercial Distribution

  • 00887919864011 ()


  • Diamond dental bur, single-use

Brasseler USA - 00887919852575

A600BLUE CD DES PIONNIERS 1P
Peter Brasseler Holdings, LLC
5027671U0
In Commercial Distribution

  • 00887919852575 ()


  • Diamond dental bur, single-use

Brasseler USA - 00887919817734

A637BLUE CD MESNIL R2092-A 1P
Peter Brasseler Holdings, LLC
5026974U0
In Commercial Distribution

  • 00887919817734 ()


  • Diamond dental bur, single-use

Brasseler USA - 00887919814252

A600BLUE CD LAFORTUNE R1673C 1P
Peter Brasseler Holdings, LLC
5026846U0
In Commercial Distribution

  • 00887919814252 ()


  • Diamond dental bur, single-use

Brasseler USA - 00887919814221

A600RED CD LAFORTUNE R1673B 1P
Peter Brasseler Holdings, LLC
5026845U0
In Commercial Distribution

  • 00887919814221 ()


  • Diamond dental bur, single-use

Brasseler USA - 00887919814191

A600PURP CD LAFORTUNE R1673A 1P
Peter Brasseler Holdings, LLC
5026844U0
In Commercial Distribution

  • 00887919814191 ()


  • Diamond dental bur, single-use

Brasseler USA - 00887919785293

A635BLUE CD FOURNIER FORTIN 1P
Peter Brasseler Holdings, LLC
5026100U0
In Commercial Distribution

  • 00887919785293 ()


  • Diamond dental bur, single-use

Brasseler USA - 00887919773207

A637BLUE CD DALLAIRE R1296-A 1P
Peter Brasseler Holdings, LLC
5026047U0
In Commercial Distribution

  • 00887919773207 ()


  • Diamond dental bur, single-use

Brasseler USA - 00887919772217

A100BLU CD CHRISTIAN BERNARD 1P
Peter Brasseler Holdings, LLC
5025991U0
In Commercial Distribution

  • 00887919772217 ()


  • Diamond dental bur, single-use

Brasseler USA - 00887919770190

A100BLUE CD AUGER R1239-A 1P
Peter Brasseler Holdings, LLC
5025803U0
In Commercial Distribution

  • 00887919770190 ()


  • Diamond dental bur, single-use

Brasseler USA - 00887919764533

A100BLUE CD BINET & ROBERT INC
Peter Brasseler Holdings, LLC
5025655U0
In Commercial Distribution

  • 00887919764533 ()


  • Diamond dental bur, single-use

Brasseler USA - 00887919763604

A100RED CD CHRISTIAN BERNARD 1P
Peter Brasseler Holdings, LLC
5025620U0
In Commercial Distribution

  • 00887919763604 ()


  • Diamond dental bur, single-use

Brasseler USA - 00887919757689

A637PURP CD STEPHANE FORTIER 1P
Peter Brasseler Holdings, LLC
5025440U0
In Commercial Distribution

  • 00887919757689 ()


  • Diamond dental bur, single-use

Brasseler USA - 00887919805687

A600PURP CD BERNARD BOUCHARD 1P
Peter Brasseler Holdings, LLC
5026606U0
In Commercial Distribution

  • 00887919805687 ()


  • Diamond dental bur, single-use

Brasseler USA - 00887919801887

A600PURPL CD MARIE-EVE MORIN 1P
Peter Brasseler Holdings, LLC
5026509U0
In Commercial Distribution

  • 00887919801887 ()


  • Diamond dental bur, single-use

Brasseler USA - 00887919669630

A600RED CD CARON R2153-A 1P
Peter Brasseler Holdings, LLC
5022092U0
In Commercial Distribution

  • 00887919669630 ()


  • Diamond dental bur, single-use

FLUOROMAP - 07613252196259

FLUOROMAP 1.0 - SALES DEMO CD
Stryker Leibinger GmbH & Co. KG
81-81022
In Commercial Distribution

  • 07613252196259 ()
81-81022

  • Robotic surgical navigation system application software

CARBO - 06973169040528

Detox Series CD Quick Pack
Wujiang City ShenLing Medical Device Co.,Ltd
CD-36050
In Commercial Distribution

  • 06973169040528 ()


  • Acupuncture needle, single-use

CARBO - 06973169040511

Detox Series CD Quick Pack
Wujiang City ShenLing Medical Device Co.,Ltd
CD-36025
In Commercial Distribution

  • 06973169040511 ()


  • Acupuncture needle, single-use

CARBO - 06973169040504

Detox Series CD Quick Pack
Wujiang City ShenLing Medical Device Co.,Ltd
CD-34050
In Commercial Distribution

  • 06973169040504 ()


  • Acupuncture needle, single-use

CD HORIZON® Spinal System - 20673978074027

SCREW 89104 CD THR PLUG
MEDTRONIC SOFAMOR DANEK, INC.
89104
In Commercial Distribution

  • 20673978074027 ()
  • 00673978074023 ()

  • Outer Diameter: 10.0 Millimeter


  • Spinal bone screw, non-bioabsorbable

VITEK®2 - 03573026609399

CD WITH 9.02 software version
BIOMERIEUX , INC.
9.02.0
In Commercial Distribution

  • 03573026609399 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD, semi-automated

CD NXT - 07613327555417

System 8 CD NXT Handpiece
STRYKER CORPORATION
4507000000
In Commercial Distribution

  • 07613327555417 ()
4507-000-000

  • Bone/joint surgical power tool motorized handpiece/set, electric, reusable

NA - 00763000208448

TAPS 9735469 CD HORIZON SOLERA
MEDTRONIC NAVIGATION, INC.
9735469
In Commercial Distribution

  • 00763000208448 ()


  • Multi-purpose stereotactic surgery system

CD HORIZON® Spinal System - 00721902267475

CD HORIZON ANTARES X-SMALL CAU
MEDTRONIC SOFAMOR DANEK, INC.
8698498
Not in Commercial Distribution

  • 00721902267475 ()

  • Length: 19.0 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

CD HORIZON® Spinal System - 00721902267468

CD HORIZON ANTARES X-SMALL ROS
MEDTRONIC SOFAMOR DANEK, INC.
8698499
Not in Commercial Distribution

  • 00721902267468 ()

  • 19mm


  • Bone-screw internal spinal fixation system, non-sterile

SOLERA - 00763000927110

TAPS 9735469 CD HORIZON SOLERA
MEDTRONIC NAVIGATION, INC.
9735469
In Commercial Distribution

  • 00763000927110 ()


  • Multi-purpose stereotactic surgery system

N/A - 00885074017082

SFTWR 9731368 CD, AUTO-INSTALL, TRACER
MEDTRONIC NAVIGATION, INC.
9731368
In Commercial Distribution

  • 00885074017082 ()


  • Multi-purpose stereotactic surgery system

N/A - 00885074494227

CD HORIZON SPIRE - CADDY LID
MEDTRONIC SOFAMOR DANEK, INC.
9241093
In Commercial Distribution

  • 00885074494227 ()


  • Instrument tray, reusable

N/A - 00885074494210

CD HORIZON SPIRE - PLATE CADDY
MEDTRONIC SOFAMOR DANEK, INC.
9241092
In Commercial Distribution

  • 00885074494210 ()


  • Instrument tray, reusable

N/A - 00885074494203

CD HORIZON SPIRE - INNER TRAY
MEDTRONIC SOFAMOR DANEK, INC.
9241091
In Commercial Distribution

  • 00885074494203 ()


  • Instrument tray, reusable

N/A - 00885074494197

CD HORIZON SPIRE - OUTER CASE
MEDTRONIC SOFAMOR DANEK, INC.
9241090
In Commercial Distribution

  • 00885074494197 ()


  • Instrument tray, reusable

Welch Allyn, Inc. - 00732094307375

Q-TEL V5.0.1 Q-PROGRESS SOFTWARE CD
WELCH ALLYN, INC.
901145
In Commercial Distribution

  • 00732094307375 ()
419733

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094307368

Q-TEL V5.0.1 Workstation Software CD
WELCH ALLYN, INC.
901145
In Commercial Distribution

  • 00732094307368 ()
413379

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094307351

QTEL v5.0.1 TOWER SOFTWARE CD
WELCH ALLYN, INC.
901145
In Commercial Distribution

  • 00732094307351 ()
419751

  • Centralized patient monitor

Guardian™ Connect - 00763000399009

KIT MMT-7820LNA GST4C LOCKOUT CD
MEDTRONIC MINIMED, INC.
MMT-7820LNA
In Commercial Distribution

  • 00763000399009 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical

U400 ImpSoft Software - B277292U400CD0

Impsoft data management & analysis software
IMPEDIMED LIMITED
2.2.0
In Commercial Distribution

  • B277292U400CD2 ()
  • B277292U400CD1 ()
  • B277292U400CD0 ()
292-U400CD

  • Bioelectrical body composition analyser

Body Composition Analysis Software - B277292DF50CD0

DF50 Body Composition Analysis Software
IMPEDIMED LIMITED
4.1.2
Not in Commercial Distribution

  • B277292DF50CD1 ()
  • B277292DF50CD0 ()
  • B277292DF50CD2 ()
292-DF50CD

  • Bioelectrical body composition analyser

CHATTANOOGA - 00888912296533

CARD MULTIMEDIA DTS
DJO, LLC
2842
In Commercial Distribution

  • 00888912296533 ()


  • Software upgrade/unlocking key

FUKUDA DENSHI - 04538612916014

No Description
FUKUDA DENSHI CO.,LTD.
FP-908LP
In Commercial Distribution

  • 04538612916014 ()


  • Software upgrade/unlocking key

FUKUDA DENSHI - 04538612916007

No Description
FUKUDA DENSHI CO.,LTD.
FP-908A
In Commercial Distribution

  • 04538612916007 ()


  • Software upgrade/unlocking key

FUKUDA DENSHI - 04538612915154

No Description
FUKUDA DENSHI CO.,LTD.
FP-811
In Commercial Distribution

  • 04538612915154 ()


  • Software upgrade/unlocking key

OTV-S500 UPGRADE PACK STROBE - 04953170458170

No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2547
In Commercial Distribution

  • 04953170458170 ()
N6216940

  • Software upgrade/unlocking key
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