World Cup Liner – Neutral Lateralised Vit-E

GUDID 09348215135805

SIGNATURE ORTHOPAEDICS PTY LTD

Non-constrained polyethylene acetabular liner

• Primary Device ID: 09348215135805
• NIH Device Record Key: e188006a-3baf-4a83-8366-84b179771604
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: World Cup Liner – Neutral Lateralised Vit-E
• Version Model Number: 111-49-3354E
• 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	09348215135805 [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 – Neutral Lateralised Vit-E]

• 09348215135836: 111-49-4358E
• 09348215135829: 111-49-4354E
• 09348215135812: 111-49-3358E
• 09348215135805: 111-49-3354E
• 09348215135799: 111-49-3350E
• 09348215135782: 111-49-2358E
• 09348215135775: 111-49-2354E
• 09348215135768: 111-49-2350E
• 09348215135751: 111-49-2346E
• 09348215135744: 111-49-1354E
• 09348215135737: 111-49-1350E
• 09348215135720: 111-49-1346E