KYPHON® HV-R® Bone Cement and KYPHON® Mixer Pack

GUDID 00613994515155

BONE CEMENT C01B HV-R WITH MIXER US

MEDTRONIC SOFAMOR DANEK, INC.

Orthopaedic cement, non-medicated Orthopaedic cement, non-medicated
Primary Device ID00613994515155
NIH Device Record Keyb98a06ae-05bb-4e85-821f-30f5702a364e
Commercial Distribution StatusIn Commercial Distribution
Brand NameKYPHON® HV-R® Bone Cement and KYPHON® Mixer Pack
Version Model NumberC01B
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 Perscriptiontrue
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
GS100613994515155 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NDNCEMENT, BONE, VERTEBROPLASTY

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 Date2015-09-01

On-Brand Devices [KYPHON® HV-R® Bone Cement and KYPHON® Mixer Pack]

00613994745569BONE CEMENT C01B HV-R WITH MIXER CAN
00613994745552BONE CEMENT C01B HV-R WITH MIXER US
00613994515155BONE CEMENT C01B HV-R WITH MIXER US
00643169097834BONE CEMENT C01B HV-R WITH MIXER US

Trademark Results [KYPHON]

Mark Image

Registration | Serial
Company
Trademark
Application Date
KYPHON
KYPHON
77920581 3837842 Dead/Cancelled
Kyphon SARL
2010-01-26
KYPHON
KYPHON
77145293 3380538 Live/Registered
MEDTRONIC HOLDING COMPANY SARL
2007-03-30
KYPHON
KYPHON
77145286 3380537 Dead/Cancelled
MEDTRONIC HOLDING COMPANY SARL
2007-03-30
KYPHON
KYPHON
76124590 2509449 Live/Registered
MEDTRONIC HOLDING COMPANY SARL
2000-09-07
KYPHON
KYPHON
75792575 2436526 Live/Registered
MEDTRONIC HOLDING COMPANY SARL
1999-09-03

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