GUDID 00763000650827

SET 9736464 BASIC INST AUTOGUIDE II EN

MEDTRONIC NAVIGATION, INC.

Multi-purpose stereotactic surgery system
Primary Device ID00763000650827
NIH Device Record Key9329e126-2264-4fb9-bde0-f1262c58dc71
Commercial Distribution StatusIn Commercial Distribution
Version Model Number9736464
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
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
GS100763000650827 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HAWNeurological stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-04
Device Publish Date2023-08-26

Devices Manufactured by MEDTRONIC NAVIGATION, INC.

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00763000738501 - Aquamantys™2025-04-01 AQM 6.0 BIPOLAR SEALER UNIT
00763000738556 - Aquamantys™2025-04-01 AQUAMANTYS 2.3 BIPOLAR SEALER UNIT
00763000972318 - N/A2025-03-31 EMITTER 9733752R FLAT CALIBRATED
00763000972325 - N/A2025-03-31 EMITTER 9735521R AXIEM 3 SIDE MOUNT
00763000979157 - N/A2025-03-31 ADHESIVE PAD 9732500XOM 25PK ENT
00763000582920 - N/A2025-03-14 TRAY 9735467 PERCUTANEOUS TRAY
00643169636231 - N/A2025-02-25 TRIAL KIT 9734959 CLYDESDALE 12X55 MM

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