GUDID 00643169693838

DRIVER NAV2024K SOLERA 4.75 STANDARD MAS

MEDTRONIC SOFAMOR DANEK, INC.

Surgical screwdriver, reusable
Primary Device ID00643169693838
NIH Device Record Keyb4ccf1d0-3f6d-4d9e-9447-90b76818e9b7
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberNAV2024K
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

Device Dimensions

Outer Diameter4.75 Millimeter
Outer Diameter4.75 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169693838 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic stereotaxic instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00643169693838]

Moist Heat or Steam Sterilization


[00643169693838]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2018-10-05
Device Publish Date2016-08-29

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

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00763000864644 - n/a2025-03-14 TOOL 4360320 IMPLANT REMOVAL TOOL
00763000864668 - T2™ Spinal System2025-03-14 DRIVER 4360520 T17 DRIVER
00763000862909 - General Instruments2025-03-11 DRIVER X981000033 RETAINING STRAIGHT T25
00763000862916 - General Instruments2025-03-11 AWL X981000035 AWL ANGLED
00763000862930 - General Instruments2025-03-11 DRIVER X981000036 RETAINING 40 DEG T25
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