Prestige LP Streamlined Instruments

GUDID 00643169752085

TRIAL 6975225 TRIAL 5X12MM

MEDTRONIC SOFAMOR DANEK, INC.

Spinal implant trial Spinal implant trial
Primary Device ID00643169752085
NIH Device Record Keyd39a9757-e061-46de-8a44-9a8d1eb59dc0
Commercial Distribution StatusIn Commercial Distribution
Brand NamePrestige LP Streamlined Instruments
Version Model Number6975225
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

Device Dimensions

Height5 Millimeter
Height5 Millimeter
Height5 Millimeter
Height5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169752085 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MJOProsthesis, intervertebral disc

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00643169752085]

Moist Heat or Steam Sterilization


[00643169752085]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-07
Device Publish Date2018-02-11

On-Brand Devices [Prestige LP Streamlined Instruments]

00643169753020RAIL PUNCH 6975408 RAIL PUNCH 8MM
00643169753013RAIL PUNCH 6975407 RAIL PUNCH 7MM
00643169753006RAIL PUNCH 6975406 RAIL PUNCH 6MM
00643169752993RAIL PUNCH 6975405 RAIL PUNCH 5MM
00643169752986GUIDE 6975208 DRILL GUIDE 8MM
00643169752979GUIDE 6975207 DRILL GUIDE 7MM
00643169752962GUIDE 6975206 DRILL GUIDE 6MM
00643169752955GUIDE 6975205 DRILL GUIDE 5MM
00643169752207TRIAL 6975288 TRIAL 8X18MM
00643169752191TRIAL 6975268 TRIAL 8X16MM
00643169752184TRIAL 6975248 TRIAL 8X14MM
00643169752177TRIAL 6975287 TRIAL 7X18MM
00643169752160TRIAL 6975267 TRIAL 7X16MM
00643169752153TRIAL 6975247 TRIAL 7X14MM
00643169752146TRIAL 6975286 TRIAL 6X18MM
00643169752139TRIAL 6975266 TRIAL 6X16MM
00643169752122TRIAL 6975246 TRIAL 6X14MM
00643169752115TRIAL 6975226 TRIAL 6X12MM
00643169752108TRIAL 6975265 TRIAL 5X16MM
00643169752092TRIAL 6975245 TRIAL 5X14MM
00643169752085TRIAL 6975225 TRIAL 5X12MM

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