World Cup Liner – Eccentric

GUDID 09348215136604

SIGNATURE ORTHOPAEDICS PTY LTD

Non-constrained polyethylene acetabular liner

• Primary Device ID: 09348215136604
• NIH Device Record Key: b2a43c42-d474-4354-aed8-d5b6a8d19f64
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: World Cup Liner – Eccentric
• Version Model Number: 111-49-2850
• Company DUNS: 751993028
• Company Name: SIGNATURE ORTHOPAEDICS PTY LTD
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09348215136604 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201278

FDA Product Code

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

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: 2024-12-11
• Device Publish Date: 2024-12-03

On-Brand Devices [World Cup Liner – Eccentric]

• 09348215136673: 111-49-4858
• 09348215136666: 111-49-4854
• 09348215136659: 111-49-3858
• 09348215136642: 111-49-3854
• 09348215136635: 111-49-3850
• 09348215136628: 111-49-2858
• 09348215136611: 111-49-2854
• 09348215136604: 111-49-2850
• 09348215136598: 111-49-2846
• 09348215136581: 111-49-1854
• 09348215136574: 111-49-1850
• 09348215136567: 111-49-1846