PRESTIGE LP™

GUDID 00613994714831

INNER SHAFT 6973050 5MM INSERTER US

MEDTRONIC SOFAMOR DANEK, INC.

Orthopaedic graft inserter Orthopaedic graft inserter
Primary Device ID00613994714831
NIH Device Record Key2602f3db-bf5a-41cf-8b4c-593765e640ff
Commercial Distribution StatusIn Commercial Distribution
Brand NamePRESTIGE LP™
Version Model Number6973050
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 Latextrue
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

Device Dimensions

Height5 Millimeter
Height5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994714831 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MJOPROSTHESIS, INTERVERTEBRAL DISC

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00613994714831]

Moist Heat or Steam Sterilization


[00613994714831]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-30

On-Brand Devices [PRESTIGE LP™]

00613994714831INNER SHAFT 6973050 5MM INSERTER US
00613994493743DISC 6972250 PRESTIGE
00613994493712DISC 6972450 PRESTIGE
00613994493675DISC 6972650 PRESTIGE
00613994490735PUNCH 6972425 RAIL
00613994490711PUNCH 6972445 RAIL
00613994490476TRIAL 6973225 IMPLANT
00613994490452TRIAL 6973245 IMPLANT
00613994490414TRIAL 6973265 IMPLANT
00613994490346GUIDE 6972525 CUTTER
00613994490322GUIDE 6972545 CUTTER

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