COLS®

GUDID 03661489661402

FOURNITURES HOSPITALIERES INDUSTRIE

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 03661489661402
• NIH Device Record Key: 5a1877ba-1e2c-41ca-bc76-9883b76bec8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COLS®
• Version Model Number: 266140 - PEEK SCREW, Ø10 / L25
• Company DUNS: 261839898
• Company Name: FOURNITURES HOSPITALIERES INDUSTRIE
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03661489661402 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113591

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2023-07-28
• Device Publish Date: 2015-10-24

On-Brand Devices [COLS®]

• 03661489662683: 266268 - PEEK SCREW, Ø12 / L20
• 03661489661426: 266142 - TAPES AND BLADE, Qty2
• 03661489661419: 266141 - TAPE, Qty1
• 03661489661402: 266140 - PEEK SCREW, Ø10 / L25
• 03661489661396: 266139 - PEEK SCREW, Ø10 / L20
• 03661489661389: 266138 - CoLS TITANIUM SCREW, Ø12 L20
• 03661489661372: 266137 - CoLS TITANIUM SCREW, Ø10 L25
• 03661489661365: 266136 - CoLS TITANIUM SCREW, Ø10 L20