KYPHON Express II Inflatable Bone Tamp

GUDID 00763000025670

BONE TAMP KE202 20/2 EXPRESS II IBT

MEDTRONIC SOFAMOR DANEK, INC.

Inflatable bone tamp
Primary Device ID00763000025670
NIH Device Record Key8c6f6b0d-3905-4644-a7b3-a89bc3221d49
Commercial Distribution StatusIn Commercial Distribution
Brand NameKYPHON Express II Inflatable Bone Tamp
Version Model NumberKE202
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
GS100763000025670 [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 Express II Inflatable Bone Tamp]

00763000025670BONE TAMP KE202 20/2 EXPRESS II IBT
00763000025656BONE TAMP KE152 15/2 EXPRESS II IBT
00763000025632BONE TAMP KE102 10/2 EXPRESS II IBT
00763000312039BONE TAMP KE152 15/2 EXPRESS II IBT
00763000312053BONE TAMP KE202 20/2 EXPRESS II IBT

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