World Cup Liner – High Wall

GUDID 09348215136338

SIGNATURE ORTHOPAEDICS PTY LTD

Non-constrained polyethylene acetabular liner

• Primary Device ID: 09348215136338
• NIH Device Record Key: c93384c3-875a-49dc-aefd-2d9fb037e1e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: World Cup Liner – High Wall
• Version Model Number: 111-49-1650
• 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	09348215136338 [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 – High Wall]

• 09348215136437: 111-49-4658
• 09348215136420: 111-49-4654
• 09348215136413: 111-49-3658
• 09348215136406: 111-49-3654
• 09348215136390: 111-49-3650
• 09348215136383: 111-49-2658
• 09348215136376: 111-49-2654
• 09348215136369: 111-49-2650
• 09348215136352: 111-49-2646
• 09348215136345: 111-49-1654
• 09348215136338: 111-49-1650
• 09348215136321: 111-49-1646