KyphoPak™ Tray

GUDID 00613994579829

CementSys KPT1005-CDS FF XPDR 10/3 1 Stp

MEDTRONIC SOFAMOR DANEK, INC.

Balloon kyphoplasty kit
Primary Device ID00613994579829
NIH Device Record Key5981796f-ebce-42a6-ad6d-13bb9f11c2ea
Commercial Distribution StatusIn Commercial Distribution
Brand NameKyphoPak™ Tray
Version Model NumberKPT1005-CDS
Company DUNS830350380
Company NameMEDTRONIC SOFAMOR DANEK, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994579829 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRXARTHROSCOPE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-07-16

On-Brand Devices [KyphoPak™ Tray]

00613994750549KIT KPT1504 KYPAK TRY 15/3 ADDL FRACTURE
00613994703972KIT KPT1502 PAKTRAY 15/3 FF W/OIS-RB
00613994703965KIT KPT1505 PAKTRY 15/3 FF W/ONESTEP-RB
00613994703941KIT KPT2005 PAKTRY 20/3 FF W/ONE STEP-RB
00613994671721CementSys KPT1505-CDS FF XPDR 15/3 1 Stp
00613994668738KIT KPT1002 KYPHOPAK TRAY 10/3 FF W/OIS
00613994579843CementSys KPT2005-CDS FF XPDR 20/3 1 Stp
00613994579836CementSys KPT1505-CDS FF XPDR 15/3 1 Stp
00613994579829CementSys KPT1005-CDS FF XPDR 10/3 1 Stp
00643169103139KIT KPT1003 KYPAK TRY 10/3 FF W/ADV OIS
00643169102989KIT KPT2005 KYPAK TRY 20/3 FF W/ONE STEP
00643169102972KIT KPT2004 KYPAK TRY 20/3 ADDL FRACTURE
00643169102965KIT KPT2003 KYPAK TRY 20/3 FF W/ADV OIS
00643169102958KIT KPT2002 KYPAK TRY 20/3 FF W/OIS
00643169102941KIT KPT1505 KYPAK TRY 15/3 FF W/ONESTEP
00643169102934KIT KPT1504 KYPAK TRY 15/3 ADDL FRACTURE
00643169102927KIT KPT1503 KYPAK TRY 15/3 FF W/ADV OIS
00643169102910KIT KPT1502 KYPAK TRY 15/3 FF W/OIS
00643169102903KIT KPT1004 KYPAK TRY 10/3 ADDL FRACTURE
00643169100671KIT KPT1001 KYPHOPAK TRAY 10/3 FF W/ITK
00643169100664KIT KPT1002 KYPHOPAK TRAY 10/3 FF W/OIS
00643169100657CEMENTSYS KPT1002-CDS OIS XPDR 10/3
00643169100640CEMENTSYS KPT1003-CDS AOIS XPDR 10/3
00643169100633KIT KPT1005 KYPAK TRY 10/3 FF W/ONESTEP
00643169100626CEMENTSYS KPT1005-CDS FF XPDR 10/3 1 STP
00643169100619KIT KPT1501 KYPHOPAK TRAY 15/3 FF W/ITK
00643169100602CEMENTSYS KPT1502-CDS OIS XPDR 15/3
00643169100596CEMENTSYS KPT1503-CDS AOIS XPDR 15/3
00643169100589CEMENTSYS KPT1505-CDS FF XPDR 15/3 1 STP
00643169100572KIT KPT2001 KYPHOPAK TRAY 20/3 FF W/ITK
00643169100565CEMENTSYS KPT2002-CDS OIS XPDR 20/3
00643169100558CEMENTSYS KPT2003-CDS AOIS XPDR 20/3
00643169100541CEMENTSYS KPT2005-CDS FF XPDR 20/3 1 STP
00643169096578BONE TAMP KIT KPX103AB FF X2 10/3 AOIS
00643169096554BONE TAMP KIT KPX103PB FF X2 10/3 1 STP
00643169096547BONE TAMP KIT KPX103RB FF X2 10/3 OIS
00643169096530BONE TAMP KIT KPX153AB FF X2 15/3 AOIS
00643169096516BONE TAMP KIT KPX153PB FF X2 15/3 1 STP
00643169096509BONE TAMP KIT KPX153RB FF X2 15/3 OIS
00643169096493BONE TAMP KIT KPX203AB FF X2 20/3 AOIS
00643169096479BONE TAMP KIT KPX203PB FF X2 20/3 1 STP
00643169096462BONE TAMP KIT KPX203RB FF X2 20/3 OIS
00613994962362BONE TAMP KIT KPX203PB FF X2 20/3 1 STP
00613994962348BONE TAMP KIT KPX153PB FF X2 15/3 1 STP
00643169456105CEMENTSYS KPT2005-CDS FF XPDR 20/3 1 STP
00643169456099CEMENTSYS KPT2003-CDS AOIS XPDR 20/3
00643169456082CEMENTSYS KPT2002-CDS OIS XPDR 20/3
00643169456075CEMENTSYS KPT1505-CDS FF XPDR 15/3 1 STP
00643169456068CEMENTSYS KPT1503-CDS AOIS XPDR 15/3
00643169456051CEMENTSYS KPT1502-CDS OIS XPDR 15/3

Trademark Results [KyphoPak]

Mark Image

Registration | Serial
Company
Trademark
Application Date
KYPHOPAK
KYPHOPAK
76220779 2540091 Live/Registered
MEDTRONIC HOLDING COMPANY SARL
2001-03-06

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