KyphoPak™ Express™ Tray

GUDID 00613994721297

KIT KPE1003 KYPAK EXP TRY 15/2 FF W/EOIS

MEDTRONIC SOFAMOR DANEK, INC.

Balloon kyphoplasty kit Balloon kyphoplasty kit
Primary Device ID00613994721297
NIH Device Record Key88a45f1e-4829-45b4-b907-d4d2cb8bf2ee
Commercial Distribution StatusIn Commercial Distribution
Brand NameKyphoPak™ Express™ Tray
Version Model NumberKPE1003
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
GS100613994721297 [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™ Express™ Tray]

00613994721303KIT KPE1004 KPHOPAK EXPRESS TRAY 15/2 AF
00613994721297KIT KPE1003 KYPAK EXP TRY 15/2 FF W/EOIS
00613994721280KIT KPE1002 KYPAK EXPRESS TRAY 10/2 AF
00613994721273KIT KPE1001 KYPAK EXP TRY 10/2 FF W/EOIS
00613994671790CementSys KPE1003-CDS FF Express 15/2
00613994579805CementSys KPE1001-CDS FF Express 10/2
00643169103122KIT KPE1004 KYPAK EXP TRY 15/2 AF
00643169103115KIT KPE1002 KYPAK EXP TRY 10/2 AF
00643169103108KIT KPE1001 KYPAK EXP TRY 10/2 FF W/EOIS
00643169100701CEMENTSYS KPE1001-CDS FF EXPRESS 10/2
00643169100695KIT KPE1003 KYPAK EXP TRY 15/2 FF W/EOIS
00643169100688CEMENTSYS KPE1003-CDS FF EXPRESS 15/2
00643169456013CEMENTSYS KPE1003-CDS FF EXPRESS 15/2
00643169456006CEMENTSYS KPE1001-CDS FF EXPRESS 10/2
00858196001352KIT KPE1001 KYPAK EXP TRY 10/2 FF W/EOIS

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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