MSD WIRE System

GUDID 20673978017826

WIRE PEARL-TIP 3512 1.2MMX37.5CM

MEDTRONIC SOFAMOR DANEK, INC.

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 20673978017826
• NIH Device Record Key: 9108862f-3488-4687-8ac6-d8abb1ffbc01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MSD WIRE System
• Version Model Number: 3512
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00673978017822 [Unit of Use]
GS1	20673978017826 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K934007

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[20673978017826]

Moist Heat or Steam Sterilization

[20673978017826]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-29

On-Brand Devices [MSD WIRE System]

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