World Cup Liner – Neutral Lateralised

GUDID 09348215135447

SIGNATURE ORTHOPAEDICS PTY LTD

Non-constrained polyethylene acetabular liner

• Primary Device ID: 09348215135447
• NIH Device Record Key: 052ca731-d947-4c7e-955a-aa88bcabe596
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: World Cup Liner – Neutral Lateralised
• Version Model Number: 111-49-3354
• 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	09348215135447 [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]

• 09348215135478: 111-49-4358
• 09348215135461: 111-49-4354
• 09348215135454: 111-49-3358
• 09348215135447: 111-49-3354
• 09348215135430: 111-49-3350
• 09348215135423: 111-49-2358
• 09348215135416: 111-49-2354
• 09348215135409: 111-49-2350
• 09348215135393: 111-49-2346
• 09348215135386: 111-49-1354
• 09348215135379: 111-49-1350
• 09348215135362: 111-49-1346