Osteo Introducer® System; CDS and BFD

GUDID 00763000557126

KIT KPX103RB-CDS-A 10/3 FF OSTEO W CDS

MEDTRONIC SOFAMOR DANEK, INC.

Balloon kyphoplasty kit
Primary Device ID00763000557126
NIH Device Record Keyda746e25-b349-427c-9e32-c7dd026bad39
Commercial Distribution StatusIn Commercial Distribution
Brand NameOsteo Introducer® System; CDS and BFD
Version Model NumberKPX103RB-CDS-A
Company DUNS830350380
Company NameMEDTRONIC SOFAMOR DANEK, INC.
Device Count1
DM Exempttrue
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 Perscriptiontrue
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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
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
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
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
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
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a cool dry place

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000557126 [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 Date2021-08-17
Device Publish Date2021-08-09

On-Brand Devices [Osteo Introducer® System; CDS and BFD]

00763000557164KIT KPX203RB-CDS-A 20/3 FF OTEO W CDS
00763000557140KIT KPX153RB-CDS-A 15/3 FF OSTEO W CDS
00763000557126KIT KPX103RB-CDS-A 10/3 FF OSTEO W CDS

Trademark Results [Osteo Introducer]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OSTEO INTRODUCER
OSTEO INTRODUCER
76127766 2603112 Live/Registered
MEDTRONIC HOLDING COMPANY SARL
2000-09-13

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