DePuy Songer® Spinal Cable System 7825-111

GUDID 10846468005389

Pioneer Surgical Technology, Inc.

Internal spinal fixation system cable, sterile

• Primary Device ID: 10846468005389
• NIH Device Record Key: 34d84939-6b98-4102-89c7-61f0c1dfd4bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DePuy Songer® Spinal Cable System
• Version Model Number: 400-120
• Catalog Number: 7825-111
• Company DUNS: 793384496
• Company Name: Pioneer Surgical Technology, 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: 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(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com
• Phone: +1(906)226-9909
• Email: labeling@resolvesurg.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10846468005389 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K935481

FDA Product Code

• HWN: Instrument, Compression
• JDQ: Cerclage, Fixation

Sterilization

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

[10846468005389]

Moist Heat or Steam Sterilization

[10846468005389]

Moist Heat or Steam Sterilization

[10846468005389]

Moist Heat or Steam Sterilization

[10846468005389]

Moist Heat or Steam Sterilization

[10846468005389]

Moist Heat or Steam Sterilization

[10846468005389]

Moist Heat or Steam Sterilization

[10846468005389]

Moist Heat or Steam Sterilization

[10846468005389]

Moist Heat or Steam Sterilization

[10846468005389]

Moist Heat or Steam Sterilization

[10846468005389]

Moist Heat or Steam Sterilization

[10846468005389]

Moist Heat or Steam Sterilization

[10846468005389]

Moist Heat or Steam Sterilization

[10846468005389]

Moist Heat or Steam Sterilization

[10846468005389]

Moist Heat or Steam Sterilization

[10846468005389]

Moist Heat or Steam Sterilization

[10846468005389]

Moist Heat or Steam Sterilization

[10846468005389]

Moist Heat or Steam Sterilization

[10846468005389]

Moist Heat or Steam Sterilization

[10846468005389]

Moist Heat or Steam Sterilization

[10846468005389]

Moist Heat or Steam Sterilization

[10846468005389]

Moist Heat or Steam Sterilization

[10846468005389]

Moist Heat or Steam Sterilization

[10846468005389]

Moist Heat or Steam Sterilization

[10846468005389]

Moist Heat or Steam Sterilization

[10846468005389]

Moist Heat or Steam Sterilization

[10846468005389]

Moist Heat or Steam Sterilization

[10846468005389]

Moist Heat or Steam Sterilization

[10846468005389]

Moist Heat or Steam Sterilization

[10846468005389]

Moist Heat or Steam Sterilization

[10846468005389]

Moist Heat or Steam Sterilization

[10846468005389]

Moist Heat or Steam Sterilization

[10846468005389]

Moist Heat or Steam Sterilization

[10846468005389]

Moist Heat or Steam Sterilization

[10846468005389]

Moist Heat or Steam Sterilization

[10846468005389]

Moist Heat or Steam Sterilization

[10846468005389]

Moist Heat or Steam Sterilization

[10846468005389]

Moist Heat or Steam Sterilization

[10846468005389]

Moist Heat or Steam Sterilization

[10846468005389]

Moist Heat or Steam Sterilization

[10846468005389]

Moist Heat or Steam Sterilization

[10846468005389]

Moist Heat or Steam Sterilization

[10846468005389]

Moist Heat or Steam Sterilization

[10846468005389]

Moist Heat or Steam Sterilization

[10846468005389]

Moist Heat or Steam Sterilization

[10846468005389]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-10-14
• Device Publish Date: 2016-11-17

On-Brand Devices [DePuy Songer® Spinal Cable System]

• 10846468005389: 400-120
• 10846468005372: 400-067