ARROW®

GUDID 03661489691324

FOURNITURES HOSPITALIERES INDUSTRIE

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 03661489691324
• NIH Device Record Key: 0bf655d2-9579-4839-ac1f-5bb16f31a977
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARROW®
• Version Model Number: 269132 - cannulated tapered reamer
• 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	03661489691324 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171789

FDA Product Code

• PHX: Shoulder Prosthesis, Reverse Configuration

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 [ARROW®]

• 03661489692406: 269240 - quick-release peripheral drill Ø5 (x2)
• 03661489691492: 269149 - cannulated long drill bit Ø5
• 03661489691485: 269148 - cannulated drill bit Ø5
• 03661489691386: 269138 - threaded pin Ø3 L170
• 03661489691324: 269132 - cannulated tapered reamer
• 03661489680175: 268017 - extended stopped drill bit Ø5
• 03661489680168: 268016 - extended cutting guide pins (x4)
• 03661489671159: 267115 - drill bit Ø3,2
• 03661489671142: 267114 - stopped drill bit Ø5