MSD WIRE System

GUDID 20681490717254

WIRE 3510 DBL SIDED SS DIA 10/10 PK

MEDTRONIC SOFAMOR DANEK, INC.

General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit
Primary Device ID20681490717254
NIH Device Record Key976e3162-f5f0-4e2e-80c6-330ed6bc091c
Commercial Distribution StatusIn Commercial Distribution
Brand NameMSD WIRE System
Version Model Number3510
Company DUNS830350380
Company NameMEDTRONIC SOFAMOR DANEK, INC.
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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

Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100681490717250 [Unit of Use]
GS120681490717254 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[20681490717254]

Moist Heat or Steam Sterilization


[20681490717254]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-21
Device Publish Date2015-09-29

On-Brand Devices [MSD WIRE System]

20681490717254WIRE 3510 DBL SIDED SS DIA 10/10 PK
20673978017826WIRE PEARL-TIP 3512 1.2MMX37.5CM
20673978017758WIRE 3508 DBL SIDED SS DIA 08/10 PK
20613994346227WIRE 3516 DBL SIDED SS DIA 16/10 PK
00721902768675CASE 3490078 MSD 3516 WIRE CADDY LID
00721902445910CASE 3490076 MSD WIRE 1.2MM CADDY LID
00721902445903CASE 3490074 MSD WIRE 1.0MM CADDY LID
00721902445897CASE 3490072 MSD WIRE 0.8MM CADDY LID
00721902445866CASE 3490040 MSD WIRE INNER TRAY
00613994728487CADDY 3490079 MSD WIRE 1.6 MM
00613994728470CADDY 3490077 MSD WIRE 1.2 MM
00613994728463CADDY 3490075 MSD WIRE 1.0 MM

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