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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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Initial Drill L 70 new profile JDZygoma
J DENTAL CARE SRL
Initial Drill L 70 new profile JDZygoma
In Commercial Distribution

  • 08056591013587 ()
ZJDDREXS170NP

  • Dental implant system
Initial Drill L 50 new profile JDZygoma
J DENTAL CARE SRL
Initial Drill L 50 new profile JDZygoma
In Commercial Distribution

  • 08056591013570 ()
ZJDDREXS150NP

  • Dental implant system
Abutment New Engaging H 3.0 JDIcon Plus
J DENTAL CARE SRL
Abutment New Engaging H 3.0 JDIcon Plus
In Commercial Distribution

  • 08056591010340 ()
ICTIB30NC.

  • Dental implant system
Abutment New Engaging H 1.5 JDIcon Plus
J DENTAL CARE SRL
Abutment New Engaging H 1.5 JDIcon Plus
In Commercial Distribution

  • 08056591010326 ()
ICTIB15NC.

  • Dental implant system
PlasmaJet Ultra Plus Console System (New Zealand)
PLASMA SURGICAL, INC
PS10-3130-NZ
In Commercial Distribution

  • M397PS103130NZ0 ()
PS10-3130-NZ

  • Plasma surgical system
PlasmaJet V3 Plus Console System (New Zealand)
PLASMA SURGICAL, INC
PS10-2130-NZ
In Commercial Distribution

  • M397PS102130NZ0 ()
PS10-2130-NZ

  • Plasma surgical system
IR ANGIO SET UP PACK NEW HAN
Cardinal Health 200, LLC
SAN23IANL1
In Commercial Distribution

  • 50197106964338 ()
  • 10197106964330 ()
SAN23IANL1

  • Cardiothoracic surgical procedure kit, medicated, single-use
SAW BLADE GENESIS II SMALL NEW STRYKER
STERILMED, INC.
SMI71440389
Not in Commercial Distribution

  • 10888551041478 ()
71440389

  • Surgical saw blade, reciprocating, single-use
5-Lead, New Telemetry, Disp,IEC,Snap,24″
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
EY6509B
In Commercial Distribution

  • 06944904054865 ()
009-004792-00

  • Multiple-patient intensive/general healthcare physiologic monitoring system
3-Lead, New Telemetry, Disp,IEC,Snap,24″
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
EY6313B
In Commercial Distribution

  • 06944904054834 ()
009-004780-00

  • Multiple-patient intensive/general healthcare physiologic monitoring system
Reservoir Gasket for Standby Model - New Style
W. A. BAUM CO., INC.
2255NS
In Commercial Distribution

  • 00810010924407 ()
2255NS

  • Aneroid manual sphygmomanometer
Complete Scale (New Style) for Standby Model
W. A. BAUM CO., INC.
2271NS
In Commercial Distribution

  • 00810010923479 ()
2271NS

  • Aneroid manual sphygmomanometer
Scale Only (New Style) for Standby Model
W. A. BAUM CO., INC.
2270NS
In Commercial Distribution

  • 00810010923462 ()
2270NS

  • Aneroid manual sphygmomanometer
NAVIOS EX TETRA SOFTWARE V2.0 NEW USER
BECKMAN COULTER IRELAND INC.
TETRA SOFTWARE V2.0 NEW USER
In Commercial Distribution

  • 15099590683276 ()
B91240

  • Laboratory instrument/analyser application software IVD
ONE Tattoo Touch USA 3-Pack (new pack)
GLOBAL PROTECTION CORP.
112006
In Commercial Distribution

  • 80726893114940 ()
  • 00726893114944 ()


  • Basic male condom, Hevea-latex
IR ANGIO SET UP PACK NEW HAN
Cardinal Health 200, LLC
SAN23IANLA
In Commercial Distribution

  • 50197106544059 ()
  • 10197106544051 ()
SAN23IANLA

  • Cardiothoracic surgical procedure kit, medicated, single-use
OPEN HEART RE OP PACK NEW HAN
Cardinal Health 200, LLC
SCV23ORNLA
In Commercial Distribution

  • 50197106544707 ()
  • 10197106544709 ()
SCV23ORNLA

  • Cardiothoracic surgical procedure kit, non-medicated, single-use
CONVENIENCE KIT FOR NEW OR REPLACEMENT DRESSING
STRADIS MEDICAL LLC
MSDC-C18300
In Commercial Distribution

  • M752MSDCC183000 ()
  • M752MSDCC183005 ()


  • Wound dressing kit, medicated
CASE 9568013 MAST QUADRANT OUTR TRAY NEW
MEDTRONIC SOFAMOR DANEK, INC.
9568013
In Commercial Distribution

  • 00885074421490 ()


  • Instrument tray, reusable
CASE 8390310 MAST QUAD LGCY OUTR NEW
MEDTRONIC SOFAMOR DANEK, INC.
8390310
In Commercial Distribution

  • 00885074421469 ()


  • Instrument tray, reusable
SM JOINT GRASPR W/ NEW LOCKING RATCHET
Smith & Nephew, Inc.
72203612
In Commercial Distribution

  • 00885554027341 ()
72203612

  • Rigid endoscopic grasping forceps, reusable
MTS PTCA KIT W/ SYRINGE YALE NEW HAVEN
MEDLINE INDUSTRIES, INC.
602500212
In Commercial Distribution

  • 20193489072799 ()
  • 10193489072792 ()
602500212

  • Angiography kit
MTO LEFT HEART KIT NEW HANOVER REG MED
MEDLINE INDUSTRIES, INC.
65141392
In Commercial Distribution

  • 10193489062304 ()
65141392

  • Angiography kit
MTO ANGIO KIT HENRY MAYO NEW HALL MEM
MEDLINE INDUSTRIES, INC.
60182193
In Commercial Distribution

  • 20193489049715 ()
  • 10193489049718 ()
60182193

  • Angiography kit
MTS NEURO KIT 2 NEW ENGLAND MED CTR
MEDLINE INDUSTRIES, INC.
601400111
In Commercial Distribution

  • 20193489071341 ()
  • 10193489071344 ()
601400111

  • Angiography kit
MTS CLOS SYS W/CIL-YALE NEW HAVEN PG
MEDLINE INDUSTRIES, INC.
602500213
In Commercial Distribution

  • 20193489072805 ()
  • 10193489072808 ()
602500213

  • Angiography kit
ACCY 3550-29 NEW PLUG CLOSED BOOT US MKT
MEDTRONIC, INC.
3550-29
Not in Commercial Distribution

  • 00613994353641 ()


  • Neurosurgical procedure kit, non-medicated, single-use
OXFORD ANKLE FUSION NAIL X-RAY TEMPLATE, NEW NAIL
ORTHO SOLUTIONS HOLDINGS LIMITED
OS333517-X-RAY-TEMPLATEII
In Commercial Distribution

  • 05055662914672 ()
OS333517-X-RAY-TEMPLATEII

  • Surgical implant template, reusable
PJ120-E (20cm Applier for New 9 Small Clip)
VITALITEC INTERNATIONAL, INC.
PJ120-E
In Commercial Distribution

  • 00850001784184 ()

  • Length: 20 Centimeter


  • Open-surgery ligation clip applier
3 Lead New NK 12 Pin Patient Cable
Advantage Medical Electronics, LLC
CB-723600
In Commercial Distribution

  • 00849593012904 ()


  • Electrical-only medical device connection cable, reusable
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