Prestige LP™ Cervical Disc System with Streamlined Instruments

GUDID 00763000200633

TRAY 6978021 8MM STREAMLINED INSTRUMENTS

MEDTRONIC SOFAMOR DANEK, INC.

Instrument tray
Primary Device ID00763000200633
NIH Device Record Key7dc1d3e0-be89-4047-b2e7-6a4d8eebe31e
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrestige LP™ Cervical Disc System with Streamlined Instruments
Version Model Number6978021
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 Usefalse
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
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
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
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000200633 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KCTSterilization wrap containers, trays, cassettes & other accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


[00763000200633]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-08-09
Device Publish Date2019-07-06

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