KYPHON Xpander II Inflatable Bone Tamp

GUDID 00763000025717

BONE TAMP KX153 15/3 XPANDER II IBT

MEDTRONIC SOFAMOR DANEK, INC.

Inflatable bone tamp
Primary Device ID00763000025717
NIH Device Record Key4efe3367-864e-4eb6-b702-667f0fbdcfa0
Commercial Distribution StatusIn Commercial Distribution
Brand NameKYPHON Xpander II Inflatable Bone Tamp
Version Model NumberKX153
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 (at max. 25°C / 77°F), dry place
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000025717 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HXGTAMP

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 II Inflatable Bone Tamp]

00763000025731BONE TAMP KX203 20/3 XPANDER II IBT
00763000025717BONE TAMP KX153 15/3 XPANDER II IBT
00763000025694BONE TAMP KX103 10/3 XPANDER II IBT

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