KYPHON® Express™ II Inflatable Bone Tamp

GUDID 00763000312015

BONE TAMP KE102 10/2 EXPRESS II IBT

MEDTRONIC SOFAMOR DANEK, INC.

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Primary Device ID	00763000312015
NIH Device Record Key	d1fea627-f431-44d4-84e9-765e611875d9
Commercial Distribution Status	In Commercial Distribution
Brand Name	KYPHON® Express™ II Inflatable Bone Tamp
Version Model Number	KE102
Company DUNS	830350380
Company Name	MEDTRONIC SOFAMOR DANEK, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com

Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place
Special Storage Condition, Specify	Between 0 and 0 *Store in a cool (at max. 25°C / 77°F), dry place

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000312015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K123771

FDA Product Code

HXG

TAMP

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2020-10-05
Device Publish Date	2020-09-25

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Trademark Results [KYPHON]

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