KYPHON Xpander Inflatable Bone Tamp

GUDID 00763000025588

TAMP K08A XPANDR INFLAT BONE SIZE 20/3

MEDTRONIC SOFAMOR DANEK, INC.

Inflatable bone tamp
Primary Device ID00763000025588
NIH Device Record Key59f22e64-c55e-4c23-b455-5b9e1bd5fb6c
Commercial Distribution StatusIn Commercial Distribution
Brand NameKYPHON Xpander Inflatable Bone Tamp
Version Model NumberK08A
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

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
GS100763000025588 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRXArthroscope

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-01-07
Device Publish Date2018-12-06

On-Brand Devices [KYPHON Xpander Inflatable Bone Tamp]

00763000025601TAMP K13A XPANDR INFLAT BONE SIZE 10/3
00763000025595TAMP K09A XPANDR INFLAT BONE SIZE 15/3
00763000025588TAMP K08A XPANDR INFLAT BONE SIZE 20/3

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