Prestige(R) Cervical Disc System

GUDID 00613994257314

CASE 6971419 PRESTIGE ST OUTER CASE

MEDTRONIC SOFAMOR DANEK, INC.

Instrument tray
Primary Device ID00613994257314
NIH Device Record Key62e4392a-3bf6-4bfd-bb86-f6f154733b5b
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrestige(R) Cervical Disc System
Version Model Number6971419
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 Usefalse
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
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
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
GS100613994257314 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FSMTRAY, SURGICAL, INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00613994257314]

Moist Heat or Steam Sterilization


[00613994257314]

Moist Heat or Steam Sterilization


[00613994257314]

Moist Heat or Steam Sterilization


[00613994257314]

Moist Heat or Steam Sterilization


[00613994257314]

Moist Heat or Steam Sterilization


[00613994257314]

Moist Heat or Steam Sterilization


[00613994257314]

Moist Heat or Steam Sterilization


[00613994257314]

Moist Heat or Steam Sterilization


[00613994257314]

Moist Heat or Steam Sterilization


[00613994257314]

Moist Heat or Steam Sterilization


[00613994257314]

Moist Heat or Steam Sterilization


[00613994257314]

Moist Heat or Steam Sterilization


[00613994257314]

Moist Heat or Steam Sterilization


[00613994257314]

Moist Heat or Steam Sterilization


[00613994257314]

Moist Heat or Steam Sterilization


[00613994257314]

Moist Heat or Steam Sterilization


[00613994257314]

Moist Heat or Steam Sterilization


[00613994257314]

Moist Heat or Steam Sterilization


[00613994257314]

Moist Heat or Steam Sterilization


[00613994257314]

Moist Heat or Steam Sterilization


[00613994257314]

Moist Heat or Steam Sterilization


[00613994257314]

Moist Heat or Steam Sterilization


[00613994257314]

Moist Heat or Steam Sterilization


[00613994257314]

Moist Heat or Steam Sterilization


[00613994257314]

Moist Heat or Steam Sterilization


[00613994257314]

Moist Heat or Steam Sterilization


[00613994257314]

Moist Heat or Steam Sterilization


[00613994257314]

Moist Heat or Steam Sterilization


[00613994257314]

Moist Heat or Steam Sterilization


[00613994257314]

Moist Heat or Steam Sterilization


[00613994257314]

Moist Heat or Steam Sterilization


[00613994257314]

Moist Heat or Steam Sterilization


[00613994257314]

Moist Heat or Steam Sterilization


[00613994257314]

Moist Heat or Steam Sterilization


[00613994257314]

Moist Heat or Steam Sterilization


[00613994257314]

Moist Heat or Steam Sterilization


[00613994257314]

Moist Heat or Steam Sterilization


[00613994257314]

Moist Heat or Steam Sterilization


[00613994257314]

Moist Heat or Steam Sterilization


[00613994257314]

Moist Heat or Steam Sterilization


[00613994257314]

Moist Heat or Steam Sterilization


[00613994257314]

Moist Heat or Steam Sterilization


[00613994257314]

Moist Heat or Steam Sterilization


[00613994257314]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-08-09
Device Publish Date2017-11-27

On-Brand Devices [Prestige(R) Cervical Disc System]

00613994286970LID 6961423 PRESTIGE SCREWS
00613994286963CADDY 6961422 PRESTIGE SCREWS
00613994257338CASE 6971421 PRESTIGE ST OUTER CASE LID
00613994257321CASE 6971420 PRESTIGE ST INNER TRAY
00613994257314CASE 6971419 PRESTIGE ST OUTER CASE

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.