World Cup Liner – 10d Face Changing

GUDID 09348215136109

SIGNATURE ORTHOPAEDICS PTY LTD

Non-constrained polyethylene acetabular liner

• Primary Device ID: 09348215136109
• NIH Device Record Key: 33834a34-1fc1-4548-8d57-c7f2a3c65f72
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: World Cup Liner – 10d Face Changing
• Version Model Number: 111-49-1754
• 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	09348215136109 [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 – 10d Face Changing]

• 09348215136192: 111-49-4758
• 09348215136185: 111-49-4754
• 09348215136178: 111-49-3758
• 09348215136161: 111-49-3754
• 09348215136154: 111-49-3750
• 09348215136147: 111-49-2758
• 09348215136130: 111-49-2754
• 09348215136123: 111-49-2750
• 09348215136116: 111-49-2746
• 09348215136109: 111-49-1754
• 09348215136093: 111-49-1750
• 09348215136086: 111-49-1746