Reamer Ø16 L140

GUDID 03661489673566

FOURNITURES HOSPITALIERES INDUSTRIE

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 03661489673566
• NIH Device Record Key: 9b9c16be-1cd3-4cb0-a0f7-b5b05c16dc5f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Reamer Ø16 L140
• Version Model Number: 267356
• 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	03661489673566 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150568

FDA Product Code

• PHX: Shoulder Prosthesis, Reverse Configuration

Sterilization

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

[03661489673566]

Moist Heat or Steam Sterilization

[03661489673566]

Moist Heat or Steam Sterilization

[03661489673566]

Moist Heat or Steam Sterilization

[03661489673566]

Moist Heat or Steam Sterilization

[03661489673566]

Moist Heat or Steam Sterilization

[03661489673566]

Moist Heat or Steam Sterilization

[03661489673566]

Moist Heat or Steam Sterilization

[03661489673566]

Moist Heat or Steam Sterilization

[03661489673566]

Moist Heat or Steam Sterilization

[03661489673566]

Moist Heat or Steam Sterilization

[03661489673566]

Moist Heat or Steam Sterilization

[03661489673566]

Moist Heat or Steam Sterilization

[03661489673566]

Moist Heat or Steam Sterilization

[03661489673566]

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

On-Brand Devices [Reamer Ø16 L140]

• 03661489676093: 267609
• 03661489673566: 267356