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

  • 00887919763604 ()


  • Diamond dental bur, single-use
A637PURP CD STEPHANE FORTIER 1P
Peter Brasseler Holdings, LLC
5025440U0
In Commercial Distribution

  • 00887919757689 ()


  • Diamond dental bur, single-use
A637BLACK CD MAIZERETS INC 1P
Peter Brasseler Holdings, LLC
5028362U0
In Commercial Distribution

  • 00887919877332 ()


  • Diamond dental bur, single-use
A600BLUE CD CLAUDETTE DION 1P
Peter Brasseler Holdings, LLC
5028056U0
In Commercial Distribution

  • 00887919865131 ()


  • Diamond dental bur, single-use
A600RED CD DUPUIS & LACOMBE 1P
Peter Brasseler Holdings, LLC
5027976U0
In Commercial Distribution

  • 00887919864103 ()


  • Diamond dental bur, single-use
A600BLUE CD DUPUIS & LACOMBE 1P
Peter Brasseler Holdings, LLC
5027975U0
In Commercial Distribution

  • 00887919864073 ()


  • Diamond dental bur, single-use
A600BLK CD DUPUIS & LACOMBE 1P
Peter Brasseler Holdings, LLC
5027974U0
In Commercial Distribution

  • 00887919864042 ()


  • Diamond dental bur, single-use
A600PURP CD DUPUIS & LACOMBE 1P
Peter Brasseler Holdings, LLC
5027973U0
In Commercial Distribution

  • 00887919864011 ()


  • Diamond dental bur, single-use
A600BLUE CD DES PIONNIERS 1P
Peter Brasseler Holdings, LLC
5027671U0
In Commercial Distribution

  • 00887919852575 ()


  • Diamond dental bur, single-use
A638BLUE CD BOUCHARD AND JUTRAS
Peter Brasseler Holdings, LLC
5027668U0
In Commercial Distribution

  • 00887919852483 ()


  • Diamond dental bur, single-use
A631RED CD J.P. BOUFFORD 1P
Peter Brasseler Holdings, LLC
5027518U0
In Commercial Distribution

  • 00887919846444 ()


  • Diamond dental bur, single-use
A635PURPLE CD J.P. BOUFFORD 1P
Peter Brasseler Holdings, LLC
5027517U0
In Commercial Distribution

  • 00887919846413 ()


  • Diamond dental bur, single-use
A600BLUE CD BLANCHETTE ET INC
Peter Brasseler Holdings, LLC
5027261U0
In Commercial Distribution

  • 00887919831259 ()


  • Diamond dental bur, single-use
A637BLACK CD MAIZERETS INC 1P
Peter Brasseler Holdings, LLC
5027217U0
In Commercial Distribution

  • 00887919828556 ()


  • Diamond dental bur, single-use
A600RED CD CARON R2153-A 1P
Peter Brasseler Holdings, LLC
5022092U0
In Commercial Distribution

  • 00887919669630 ()


  • Diamond dental bur, single-use
CD ASSY PATHFINDER SL 1.9
SPACELABS HEALTHCARE (WASHINGTON), INC
Pathfinder SL
In Commercial Distribution

  • 10841522124617 ()
063-2468-00

  • Electrocardiographic long-term ambulatory recording analyser
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
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
CD ASSY PATHFINDER SL 1.8.0
SPACELABS HEALTHCARE (WASHINGTON), INC
Pathfinder SL
In Commercial Distribution

  • 10841522118128 ()
063-2467-00

  • Electrocardiographic long-term ambulatory recording analyser
QTEL v5.0.1 eSIGNATURE SOFTWARE CD
WELCH ALLYN, INC.
901145
In Commercial Distribution

  • 00817655023106 ()
419734

  • Centralized patient monitor
STRIP-MEDI 1/2X4 3/CD
MEDLINE INDUSTRIES, INC.
DNSC29749
In Commercial Distribution

  • 40884389476308 ()
  • 10884389476307 ()
DNSC29749

  • General surgical procedure kit, non-medicated, single-use
BeatScope 1.1a CD + User's Guide
Finapres Medical Systems B.V.
BeatScope 1.1a
In Commercial Distribution

  • 08719327003749 ()
FP_900702

  • Patient monitoring system module, blood pressure, noninvasive
BeatScope Easy CD + User's Guide
Finapres Medical Systems B.V.
BeatScope Easy
In Commercial Distribution

  • 08719327003732 ()
FP_902701

  • Patient monitoring system module, blood pressure, noninvasive
CD WITH 9.02 software version
BIOMERIEUX , INC.
9.02.0
In Commercial Distribution

  • 03573026609399 ()


  • Microorganism identification/antimicrobial-susceptibility analyser IVD, semi-automated
syngo Dynamics VA20F CD Label
Siemens Healthcare GmbH
10745437
In Commercial Distribution

  • 04056869227054 ()


  • Radiological PACS software
FCP BIPOLAR 4.5 CD FM
MEDLINE INDUSTRIES, INC.
DYNJBIPLR05A
In Commercial Distribution

  • 10888277842069 ()
  • 40888277842060 ()
DYNJBIPLR05A

  • General surgical procedure kit, non-medicated, reusable
C-D&C CONE BIOPSY PACK
MEDLINE INDUSTRIES, INC.
DYNJ49697
In Commercial Distribution

  • 10888277873216 ()
DYNJ49697

  • General surgical procedure kit, non-medicated, reusable
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
Detox Series CD Quick Pack
Wujiang City ShenLing Medical Device Co.,Ltd
CD-36050
In Commercial Distribution

  • 06973169040528 ()


  • Acupuncture needle, single-use
Detox Series CD Quick Pack
Wujiang City ShenLing Medical Device Co.,Ltd
CD-36025
In Commercial Distribution

  • 06973169040511 ()


  • Acupuncture needle, single-use
Detox Series CD Quick Pack
Wujiang City ShenLing Medical Device Co.,Ltd
CD-34050
In Commercial Distribution

  • 06973169040504 ()


  • Acupuncture needle, single-use
TAPS 9735469 CD HORIZON SOLERA
MEDTRONIC NAVIGATION, INC.
9735469
In Commercial Distribution

  • 00763000208448 ()


  • Multi-purpose stereotactic surgery system
TAPS 9735469 CD HORIZON SOLERA
MEDTRONIC NAVIGATION, INC.
9735469
In Commercial Distribution

  • 00763000927110 ()


  • Multi-purpose stereotactic surgery system
Q-TEL V5.0.1 Q-PROGRESS SOFTWARE CD
WELCH ALLYN, INC.
901145
In Commercial Distribution

  • 00732094307375 ()
419733

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

  • 00732094307368 ()
413379

  • Centralized patient monitor
QTEL v5.0.1 TOWER SOFTWARE CD
WELCH ALLYN, INC.
901145
In Commercial Distribution

  • 00732094307351 ()
419751

  • Centralized patient monitor
SFTWR 9731368 CD, AUTO-INSTALL, TRACER
MEDTRONIC NAVIGATION, INC.
9731368
In Commercial Distribution

  • 00885074017082 ()


  • Multi-purpose stereotactic surgery system
CD HORIZON SPIRE - CADDY LID
MEDTRONIC SOFAMOR DANEK, INC.
9241093
In Commercial Distribution

  • 00885074494227 ()


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

  • 00885074494210 ()


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

  • 00885074494203 ()


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

  • 00885074494197 ()


  • Instrument tray, reusable
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 ANTARES X-SMALL ROS
MEDTRONIC SOFAMOR DANEK, INC.
8698499
Not in Commercial Distribution

  • 00721902267468 ()

  • 19mm


  • Bone-screw internal spinal fixation system, non-sterile
KIT MMT-7820LNA GST4C LOCKOUT CD
MEDTRONIC MINIMED, INC.
MMT-7820LNA
In Commercial Distribution

  • 00763000399009 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical
Impsoft data management & analysis software
IMPEDIMED LIMITED
2.2.0
In Commercial Distribution

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

  • Bioelectrical body composition analyser
DF50 Body Composition Analysis Software
IMPEDIMED LIMITED
4.1.2
Not in Commercial Distribution

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

  • Bioelectrical body composition analyser
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2547
In Commercial Distribution

  • 04953170458170 ()
N6216940

  • Software upgrade/unlocking key
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2511
In Commercial Distribution

  • 04953170445453 ()
N6189440

  • Software upgrade/unlocking key
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2383
In Commercial Distribution

  • 04953170431906 ()
N6157530

  • Software upgrade/unlocking key
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-2381
In Commercial Distribution

  • 04953170431883 ()
N6157330

  • Software upgrade/unlocking key
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