World Cup Liner – 20d Hood Lateralised Vit-E

GUDID 09348215136079

SIGNATURE ORTHOPAEDICS PTY LTD

Non-constrained polyethylene acetabular liner

• Primary Device ID: 09348215136079
• NIH Device Record Key: e9cd64b3-8a73-48eb-b708-05a7d7a3db28
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: World Cup Liner – 20d Hood Lateralised Vit-E
• Version Model Number: 111-49-4558E
• 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	09348215136079 [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 – 20d Hood Lateralised Vit-E]

• 09348215136079: 111-49-4558E
• 09348215136062: 111-49-4554E
• 09348215136055: 111-49-3558E
• 09348215136048: 111-49-3554E
• 09348215136031: 111-49-3550E
• 09348215136024: 111-49-2558E
• 09348215136017: 111-49-2554E
• 09348215136000: 111-49-2550E
• 09348215135997: 111-49-2546E
• 09348215135980: 111-49-1554E
• 09348215135973: 111-49-1550E
• 09348215135966: 111-49-1546E