World Cup Liner – 10d Face Changing Vit-E

GUDID 09348215136307

SIGNATURE ORTHOPAEDICS PTY LTD

Non-constrained polyethylene acetabular liner

• Primary Device ID: 09348215136307
• NIH Device Record Key: 9f2c7433-2588-49bf-b654-15285bfd7a6b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: World Cup Liner – 10d Face Changing Vit-E
• Version Model Number: 111-49-4754E
• 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	09348215136307 [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 Vit-E]

• 09348215136314: 111-49-4758E
• 09348215136307: 111-49-4754E
• 09348215136291: 111-49-3758E
• 09348215136284: 111-49-3754E
• 09348215136277: 111-49-3750E
• 09348215136260: 111-49-2758E
• 09348215136253: 111-49-2754E
• 09348215136246: 111-49-2750E
• 09348215136239: 111-49-2746E
• 09348215136222: 111-49-1754E
• 09348215136215: 111-49-1750E
• 09348215136208: 111-49-1746E