World Cup Liner - 20° Hood Vit-E

GUDID 09348215134068

SIGNATURE ORTHOPAEDICS PTY LTD

Non-constrained polyethylene acetabular liner

• Primary Device ID: 09348215134068
• NIH Device Record Key: 0362cbc4-f943-426e-9d2e-c0996012369f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: World Cup Liner - 20° Hood Vit-E
• Version Model Number: 111-49-3258E
• 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	09348215134068 [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: 2024-10-14
• Device Publish Date: 2024-10-04

On-Brand Devices [World Cup Liner - 20° Hood Vit-E ]

• 09348215134112: 111-49-3248E
• 09348215134082: 111-49-4258E
• 09348215134075: 111-49-4254E
• 09348215134068: 111-49-3258E
• 09348215134051: 111-49-3254E
• 09348215134044: 111-49-3250E
• 09348215134037: 111-49-2258E
• 09348215134020: 111-49-2254E
• 09348215134013: 111-49-2250E
• 09348215134006: 111-49-2246E
• 09348215133993: 111-49-1254E
• 09348215133986: 111-49-1250E
• 09348215133979: 111-49-1246E