Kyphon V Premium Vertebroplasty

GUDID 00763000026738

VP 13GA BIOPSY VPB11 BIOPSY /TAMP

MEDTRONIC SOFAMOR DANEK, INC.

Bone access cannula Bone access cannula
Primary Device ID00763000026738
NIH Device Record Keycc6125dd-8890-4c6d-aec3-203d0be6878a
Commercial Distribution StatusIn Commercial Distribution
Brand NameKyphon V Premium Vertebroplasty
Version Model NumberVPB11
Company DUNS830350380
Company NameMEDTRONIC SOFAMOR DANEK, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool, dry place

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000026738 [Primary]

FDA Product Code

MJGDEVICE, PERCUTANEOUS, BIOPSY

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-11-28
Device Publish Date2018-10-28

On-Brand Devices [Kyphon V Premium Vertebroplasty]

00763000026820VP BONE ACCESS VPT13D 13GA TROCAR/BEVEL
00763000026813BONE ACCESS TOOLS VPT13B 13GA BEVEL
00763000026806VP BONE ACCESS VPT11D 11GA TROCAR/BEVEL
00763000026790VP BONE ACCESS VPT11B 11GA BEVEL
00763000026776TOOLKIT VPT01B VP NEEDLE SET STR 10 GA
00763000026769VP 15GA BIOPSY KIT VPB13D W/13GA ACCESS
00763000026752VP 15GA BIOPSY VPB13 BIOPSY /TAMP
00763000026745VP 13GA BIOPSY KIT VPB11D W/11GA ACCESS
00763000026738VP 13GA BIOPSY VPB11 BIOPSY /TAMP

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