ARROW Off-Centred Humeral Insert

GUDID 03661489719158

FOURNITURES HOSPITALIERES INDUSTRIE

Total reverse shoulder prosthesis

• Primary Device ID: 03661489719158
• NIH Device Record Key: f5b56f08-a54e-4789-b8ad-70bd289045cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARROW Off-Centred Humeral Insert
• Version Model Number: 271915 - Off-centred humeral insert Ø36 H05 ARROW
• 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: true
• 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	03661489719158 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232226

FDA Product Code

• PHX: Shoulder Prosthesis, Reverse Configuration

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-15
• Device Publish Date: 2023-09-07

On-Brand Devices [ARROW Off-Centred Humeral Insert ]

• 03661489720154: 272015 - ARROW TRIAL HUMERAL INSERT OFF-CENTRED D4
• 03661489720147: 272014 - ARROW TRIAL HUMERAL INSERT OFF-CENTRED D4
• 03661489720130: 272013 - ARROW TRIAL HUMERAL INSERT OFF-CENTRED D4
• 03661489720123: 272012 - ARROW TRIAL HUMERAL INSERT OFF-CENTRED D3
• 03661489720116: 272011 - ARROW TRIAL HUMERAL INSERT OFF-CENTRED D3
• 03661489720109: 272010 - ARROW TRIAL HUMERAL INSERT OFF-CENTRED D3
• 03661489720093: 272009 - ARROW TRIAL HUMERAL INSERT OFF-CENTRED D3
• 03661489720086: 272008 - ARROW TRIAL HUMERAL INSERT OFF-CENTRED D3
• 03661489720079: 272007 - ARROW TRIAL HUMERAL INSERT OFF-CENTRED D3
• 03661489719226: 271922 - Off-centred humerak insert Ø42 H10 ARROW
• 03661489719219: 271921 - Off-centred humeral insert Ø42 H05 ARROW
• 03661489719202: 271920 - Off-centred humeral insert Ø42 H00 ARROW
• 03661489719196: 271919 - Off-centred humeral insert Ø39 H10 ARROW
• 03661489719189: 271918 - Off-centred humeral insert Ø39 H05 ARROW
• 03661489719172: 271917 - Off-centred humeral insert Ø39 H00 ARROW
• 03661489719165: 271916 - Off-centred humeral insert Ø36 H10 ARROW
• 03661489719158: 271915 - Off-centred humeral insert Ø36 H05 ARROW
• 03661489719141: 271914 - Off-centred humeral insert Ø36 H00 ARROW