World Cup Liner – High Wall Vit-E

GUDID 09348215136550

SIGNATURE ORTHOPAEDICS PTY LTD

Non-constrained polyethylene acetabular liner

• Primary Device ID: 09348215136550
• NIH Device Record Key: b014c25b-e7ec-4bee-b6e8-4fe9c5e29530
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: World Cup Liner – High Wall Vit-E
• Version Model Number: 111-49-4658E
• 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	09348215136550 [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 Vit-E]

• 09348215136550: 111-49-4658E
• 09348215136543: 111-49-4654E
• 09348215136536: 111-49-3658E
• 09348215136529: 111-49-3654E
• 09348215136512: 111-49-3650E
• 09348215136505: 111-49-2658E
• 09348215136499: 111-49-2654E
• 09348215136482: 111-49-2650E
• 09348215136475: 111-49-2646E
• 09348215136468: 111-49-1654E
• 09348215136451: 111-49-1650E
• 09348215136444: 111-49-1646E