GUDID 00643169966383

REDUCING TUBE 9735734 4.0MM CRANIAL

MEDTRONIC NAVIGATION, INC.

Neurological stereotactic surgery system
Primary Device ID00643169966383
NIH Device Record Key1cc57e02-a5cd-4c4a-b97a-09d99f9cb612
Commercial Distribution StatusIn Commercial Distribution
Version Model Number9735734
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 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 Identifiers

Device Issuing AgencyDevice ID
GS100643169966383 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00643169966383]

Moist Heat or Steam Sterilization


[00643169966383]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-10-08

Devices Manufactured by MEDTRONIC NAVIGATION, INC.

00763000927127 - Medtronic2024-12-13 INST SET 9735283 SOLERA 5.5/6.0 DRVR
00763000927189 - Medtronic2024-12-13 INST SET 9734495 REFERENCING STD
00763000927233 - Medtronic2024-12-13 INST SET 9734494 TACTILE PROBES
00763000922412 - Medtronic2024-11-25 INST SET 9733935 CRANIAL PASSIVE
00763000927035 - NavLock™2024-11-25 INST SET 9734833 UNIVERSAL NAVLOCK
00763000927042 - NavLock™2024-11-25 INST SET 9734834 CAPSTONE TRIALS
00763000927059 - NavLock™2024-11-25 INST SET 9734835 CLYDESDALE TRIALS
00763000927066 - Medtronic2024-11-25 INST SET 9734836 TLIF/DLIF INSERTER

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