ORIENTATOR FOR IMPACTOR HANDLE

GUDID 03661489413278

FOURNITURES HOSPITALIERES INDUSTRIE

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 03661489413278
• NIH Device Record Key: 65a8b65f-3d4e-4015-9e2b-eb88df757b1a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORIENTATOR FOR IMPACTOR HANDLE
• Version Model Number: 241327
• 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	03661489413278 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K961388

FDA Product Code

• MEH: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

Sterilization

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

[03661489413278]

Moist Heat or Steam Sterilization

[03661489413278]

Moist Heat or Steam Sterilization

[03661489413278]

Moist Heat or Steam Sterilization

[03661489413278]

Moist Heat or Steam Sterilization

[03661489413278]

Moist Heat or Steam Sterilization

[03661489413278]

Moist Heat or Steam Sterilization

[03661489413278]

Moist Heat or Steam Sterilization

[03661489413278]

Moist Heat or Steam Sterilization

[03661489413278]

Moist Heat or Steam Sterilization

[03661489413278]

Moist Heat or Steam Sterilization

[03661489413278]

Moist Heat or Steam Sterilization

[03661489413278]

Moist Heat or Steam Sterilization

[03661489413278]

Moist Heat or Steam Sterilization

[03661489413278]

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

Devices Manufactured by FOURNITURES HOSPITALIERES INDUSTRIE

• 03661489481109 - TELEGRAPH®: 2024-02-19
• 03661489481116 - TELEGRAPH®: 2024-02-19
• 03661489481123 - TELEGRAPH®: 2024-02-19
• 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