Medtronic Reusable Instrument

GUDID 00885074354330

INSERTER 6279011 PSR STRUT INNER SHAFT

MEDTRONIC SOFAMOR DANEK, INC.

Spinal implant trial
Primary Device ID00885074354330
NIH Device Record Keyc34131b0-0be9-42e1-88b4-df8175845a99
Commercial Distribution StatusIn Commercial Distribution
Brand NameMedtronic Reusable Instrument
Version Model Number6279011
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100885074354330 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQPSPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00885074354330]

Moist Heat or Steam Sterilization

[00885074354330]

Moist Heat or Steam Sterilization

[00885074354330]

Moist Heat or Steam Sterilization

[00885074354330]

Moist Heat or Steam Sterilization

[00885074354330]

Moist Heat or Steam Sterilization

[00885074354330]

Moist Heat or Steam Sterilization

[00885074354330]

Moist Heat or Steam Sterilization

[00885074354330]

Moist Heat or Steam Sterilization

[00885074354330]

Moist Heat or Steam Sterilization

[00885074354330]

Moist Heat or Steam Sterilization

[00885074354330]

Moist Heat or Steam Sterilization

[00885074354330]

Moist Heat or Steam Sterilization

[00885074354330]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-07
Device Publish Date2015-08-19

On-Brand Devices [Medtronic Reusable Instrument]

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00643169405332DISTRACTOR/TRIAL X0613946 3DEG 8X9X22
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00643169405318DISTRACTOR/TRIAL X0613944 3DEG 8X8X22
00643169405301DISTRACTOR/TRIAL X06131003 9DEG 10X12X26
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00643169405288DISTRACTOR/TRIAL X06131001 9DEG 10X11X26
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00643169405240DISTRACTOR/TRIAL X0613997 9DEG 10X9X26
00643169405233DISTRACTOR/TRIAL X0613996 9DEG 10X9X22
00643169405226DISTRACTOR/TRIAL X0613995 9DEG 10X8X26
00643169405219DISTRACTOR/TRIAL X0613994 9DEG 10X8X22
00643169405202DISTRACTOR/TRIAL X0613993 6DEG 10X12X26
00643169405196DISTRACTOR/TRIAL X0613992 6DEG 10X12X22
00643169405189DISTRACTOR/TRIAL X0613991 6DEG 10X11X26
00643169405172DISTRACTOR/TRIAL X0613990 6DEG 10X11X22
00643169405165DISTRACTOR/TRIAL X0613989 6DEG 10X10X26
00643169405158DISTRACTOR/TRIAL X0613988 6DEG 10X10X22
00643169405141DISTRACTOR/TRIAL X0613987 6DEG 10X9X26
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00643169405073DISTRACTOR/TRIAL X0613980 3DEG 10X11X22
00643169405066DISTRACTOR/TRIAL X0613979 3DEG 10X10X26
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