World Cup Liner – Eccentric Vit-E

GUDID 09348215136888

SIGNATURE ORTHOPAEDICS PTY LTD

Non-constrained polyethylene acetabular liner

• Primary Device ID: 09348215136888
• NIH Device Record Key: 90596f73-8934-4617-a0ed-1a15c6fa17c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: World Cup Liner – Eccentric Vit-E
• Version Model Number: 111-49-3854E
• 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	09348215136888 [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 Vit-E]

• 09348215136918: 111-49-4858E
• 09348215136901: 111-49-4854E
• 09348215136895: 111-49-3858E
• 09348215136888: 111-49-3854E
• 09348215136871: 111-49-3850E
• 09348215136864: 111-49-2858E
• 09348215136857: 111-49-2854E
• 09348215136840: 111-49-2850E
• 09348215136833: 111-49-2846E
• 09348215136826: 111-49-1854E
• 09348215136819: 111-49-1850E
• 09348215136802: 111-49-1846E