World Cup Liner – Neutral Vit-E

GUDID 09348215133795

SIGNATURE ORTHOPAEDICS PTY LTD

Non-constrained polyethylene acetabular liner

• Primary Device ID: 09348215133795
• NIH Device Record Key: b0f3f16b-70db-4134-b679-e5d8da5a2ebb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: World Cup Liner – Neutral Vit-E
• Version Model Number: 111-49-2058E
• 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	09348215133795 [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: 2024-10-14
• Device Publish Date: 2024-10-04

On-Brand Devices [World Cup Liner – Neutral Vit-E ]

• 09348215133849: 111-49-4058E
• 09348215133832: 111-49-4054E
• 09348215133825: 111-49-3058E
• 09348215133818: 111-49-3054E
• 09348215133801: 111-49-3050E
• 09348215133795: 111-49-2058E
• 09348215133788: 111-49-2054E
• 09348215133771: 111-49-2050E
• 09348215133764: 111-49-2046E
• 09348215133757: 111-49-1054E
• 09348215133740: 111-49-1050E
• 09348215133733: 111-49-1046E