CoLS retrograde reamer D10

GUDID 03661489501012

FOURNITURES HOSPITALIERES INDUSTRIE

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 03661489501012
• NIH Device Record Key: 87658624-6fd6-4870-b13d-c6a98b6b9e91
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CoLS retrograde reamer D10
• Version Model Number: 250101
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	03661489501012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113591

FDA Product Code

• MBI: Fastener, Fixation, Nondegradable, Soft Tissue

Sterilization

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

[03661489501012]

Moist Heat or Steam Sterilization

[03661489501012]

Moist Heat or Steam Sterilization

[03661489501012]

Moist Heat or Steam Sterilization

[03661489501012]

Moist Heat or Steam Sterilization

[03661489501012]

Moist Heat or Steam Sterilization

[03661489501012]

Moist Heat or Steam Sterilization

[03661489501012]

Moist Heat or Steam Sterilization

[03661489501012]

Moist Heat or Steam Sterilization

[03661489501012]

Moist Heat or Steam Sterilization

[03661489501012]

Moist Heat or Steam Sterilization

[03661489501012]

Moist Heat or Steam Sterilization

[03661489501012]

Moist Heat or Steam Sterilization

[03661489501012]

Moist Heat or Steam Sterilization

[03661489501012]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-05-03
• Device Publish Date: 2019-03-13

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• 03661489481130 - TELEGRAPH®: 2024-02-19
• 03661489500114 - TELEGRAPH®: 2024-02-19
• 03661489500138 - TELEGRAPH®: 2024-02-19
• 03661489500145 - TELEGRAPH®: 2024-02-19
• 03661489500169 - TELEGRAPH®: 2024-02-19