CODMAN SOFWIRE 464019

GUDID 10705034002262

CODMAN SOFWIRE SS Single Cable with Leader, 1 Cinch, 1 Tightener

Cerenovus, Inc.

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile

• Primary Device ID: 10705034002262
• NIH Device Record Key: 00fe798f-bd57-4536-acac-9ed23048f9d3
• Commercial Distribution Discontinuation: 2018-11-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: CODMAN SOFWIRE
• Version Model Number: 46-4019
• Catalog Number: 464019
• Company DUNS: 607846297
• Company Name: Cerenovus, Inc.
• Device Count: 1
• 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: true
• 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)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705034002262 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K923869

FDA Product Code

• JDQ: CERCLAGE, FIXATION

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2023-09-15
• Device Publish Date: 2015-09-24

On-Brand Devices [CODMAN SOFWIRE]

• 10705034002286: CODMAN SOFWIRE SS Ti Single Cable with Leader, 1 Cinch, 1 Tightener
• 10705034002262: CODMAN SOFWIRE SS Single Cable with Leader, 1 Cinch, 1 Tightener
• 10705034002224: CODMAN SOF'WIRE Instrument Kit