Kyphon Express Bone Biopsy Device

GUDID 00763000026875

BONE BIOPSY DEVICE F07A TAPERED SIZE 2

MEDTRONIC SOFAMOR DANEK, INC.

Bone access cannula
Primary Device ID00763000026875
NIH Device Record Key79d3254b-73f1-4633-90dd-1f4d34a6c7b9
Commercial Distribution StatusIn Commercial Distribution
Brand NameKyphon Express Bone Biopsy Device
Version Model NumberF07A
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 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
GS100763000026875 [Primary]

FDA Product Code

KIHDISPENSER, CEMENT

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

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

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