World Cup Liner – Eccentric 10d Hood

GUDID 09348215136765

SIGNATURE ORTHOPAEDICS PTY LTD

Non-constrained polyethylene acetabular liner

• Primary Device ID: 09348215136765
• NIH Device Record Key: 214daa76-a1ef-4cd4-be53-35864cab5a92
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: World Cup Liner – Eccentric 10d Hood
• Version Model Number: 111-49-3954
• 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	09348215136765 [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 – Eccentric 10d Hood]

• 09348215136796: 111-49-4958
• 09348215136789: 111-49-4954
• 09348215136772: 111-49-3958
• 09348215136765: 111-49-3954
• 09348215136758: 111-49-3950
• 09348215136741: 111-49-2958
• 09348215136734: 111-49-2954
• 09348215136727: 111-49-2950
• 09348215136710: 111-49-2946
• 09348215136703: 111-49-1954
• 09348215136697: 111-49-1950
• 09348215136680: 111-49-1946