CoLS ®

GUDID 03661489638831

FOURNITURES HOSPITALIERES INDUSTRIE

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 03661489638831
• NIH Device Record Key: 8579c985-566b-4b08-948d-b36f81f4b7bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CoLS ®
• Version Model Number: 263883 - Set of two pins sterile D2.4 LG 230MM
• 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: false
• 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	03661489638831 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113591

FDA Product Code

• MBI: Fastener, Fixation, Nondegradable, Soft Tissue

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-05-03
• Device Publish Date: 2018-10-30

On-Brand Devices [CoLS ®]

• 03661489666391: 266639 - CoLS® 1.8mm disposable screw pin
• 03661489666384: 266638 - CoLS® 4.5mm disposable drill
• 03661489666377: 266637 - CoLS® 2.4 mm disposable guide pin
• 03661489666360: 266636 - CoLS® disposable instruments
• 03661489638831: 263883 - Set of two pins sterile D2.4 LG 230MM