Navigated NIM-SPINE®

GUDID 00643169555495

PAK 9733497 NAV NIM-SPINE PEDICLE ACC KT

MEDTRONIC NAVIGATION, INC.

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Primary Device ID00643169555495
NIH Device Record Key74117b51-d21b-47d4-946a-462ba1d92aa6
Commercial Distribution StatusIn Commercial Distribution
Brand NameNavigated NIM-SPINE®
Version Model Number9733497
Company DUNS835233107
Company NameMEDTRONIC NAVIGATION, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169555495 [Primary]

FDA Product Code

MAXIntervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-11-09
Device Publish Date2020-10-31

Devices Manufactured by MEDTRONIC NAVIGATION, INC.

00763000768744 - StealthStation S82023-12-05 SW KIT 9735736 S8 2.1 ENT
00763000768867 - StealthStation S82023-12-05 SW KIT 9735740 S8 2.1 SPINE
00763000768980 - StealthStation S82023-12-05 SW KIT 9735919 S8 2.1 SPINE PLAN STATION
00763000769017 - StealthStation S82023-12-05 SW KIT 9735920 S8 2.1 ENT PLAN STATION
00763000769123 - StealthStation S82023-12-05 SW KIT 9736226 FLEX 2.1 ENT
00763000769192 - StealthStation S82023-12-05 SW KIT 9736350 S8 2.1 AIR
00763000769208 - StealthStation S82023-12-05 SFW KIT 9736186 STEALTH-MIDAS MR8
00763000768775 - StealthStation S82023-12-04 SW KIT 9735737 S8 2.1 CRAN

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