No

GUDID 00763000548544

SLEEVE NAV5599007 NAV KEY DPTH STOP SHNK

MEDTRONIC NAVIGATION, INC.

Surgical screwdriver, reusable
Primary Device ID00763000548544
NIH Device Record Keyc0430b12-65b3-4d06-ac02-c0900b4a74cd
Commercial Distribution StatusIn Commercial Distribution
Brand NameNo
Version Model NumberNAV5599007
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000548544 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic stereotaxic instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00763000548544]

Moist Heat or Steam Sterilization


[00763000548544]

Moist Heat or Steam Sterilization


[00763000548544]

Moist Heat or Steam Sterilization


[00763000548544]

Moist Heat or Steam Sterilization


[00763000548544]

Moist Heat or Steam Sterilization


[00763000548544]

Moist Heat or Steam Sterilization


[00763000548544]

Moist Heat or Steam Sterilization


[00763000548544]

Moist Heat or Steam Sterilization


[00763000548544]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-20
Device Publish Date2021-09-11

Devices Manufactured by MEDTRONIC NAVIGATION, INC.

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00763000738426 - AxiEM™2025-04-07 PATIENT TRACKER 9734887XOM NON-INVASIVE
00763000738457 - AxiEM™2025-04-07 INSTRUMENT TRACKER 9733533XOM ENT 1PK
00763000738471 - AxiEM™2025-04-07 PATIENT TRACKER 9733534XOM ENT 1PK
00763000738495 - Aquamantys™2025-04-01 AQUAMANTYS 9.5 XL BIPOLAR SEALER DEVICE
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

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