GUDID 00763000878818

INSTRUMENT 803-043 GUIDEWIRE

MEDTRONIC SOFAMOR DANEK, INC.

Orthopaedic guidewire, reusable
Primary Device ID00763000878818
NIH Device Record Key26b229c5-1814-4dfb-9a6a-b5512888356c
Commercial Distribution StatusIn Commercial Distribution
Version Model Number803-043
Company DUNS830350380
Company NameMEDTRONIC SOFAMOR DANEK, INC.
Device Count6
DM Exemptfalse
Pre-market Exempttrue
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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000878818 [Unit of Use]
GS120763000878812 [Primary]

FDA Product Code

MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00763000878818]

Moist Heat or Steam Sterilization


[00763000878818]

Moist Heat or Steam Sterilization


[00763000878818]

Moist Heat or Steam Sterilization


[00763000878818]

Moist Heat or Steam Sterilization


[00763000878818]

Moist Heat or Steam Sterilization


[00763000878818]

Moist Heat or Steam Sterilization


[00763000878818]

Moist Heat or Steam Sterilization


[00763000878818]

Moist Heat or Steam Sterilization


[00763000878818]

Moist Heat or Steam Sterilization


[00763000878818]

Moist Heat or Steam Sterilization


[00763000878818]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-16
Device Publish Date2024-12-06

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

00643169601130 - n/a2025-03-10 DRIVER 4360520 T17 DRIVER
00763000854966 - n/a2025-03-10 INSTRUMENT 6248041 10X14X11 TRIAL
00763000854973 - n/a2025-03-10 INSTRUMENT 6248064 10X16X14 TRIAL
00763000854997 - n/a2025-03-10 INSTRUMENT 6248141 11X14X11 TRIAL
00763000855000 - n/a2025-03-10 INSTRUMENT 6248164 11X16X14 TRIAL
00763000855055 - n/a2025-03-10 INSTRUMENT 6248341 13X14X11 TRIAL
00763000855147 - n/a2025-03-10 INSTRUMENT 6248641 6X14X11 TRIAL
00763000855178 - n/a2025-03-10 INSTRUMENT 6248741 7X14X11 TRIAL

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