World Cup Liner – 10d Hood Lateralised Vit-E

GUDID 09348215135928

SIGNATURE ORTHOPAEDICS PTY LTD

Non-constrained polyethylene acetabular liner

• Primary Device ID: 09348215135928
• NIH Device Record Key: 02c05dd2-49cc-4564-aad4-c30f38c8397b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: World Cup Liner – 10d Hood Lateralised Vit-E
• Version Model Number: 111-49-3454E
• 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	09348215135928 [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 Hood Lateralised Vit-E]

• 09348215135959: 111-49-4458E
• 09348215135942: 111-49-4454E
• 09348215135935: 111-49-3458E
• 09348215135928: 111-49-3454E
• 09348215135911: 111-49-3450E
• 09348215135904: 111-49-2458E
• 09348215135898: 111-49-2454E
• 09348215135881: 111-49-2450E
• 09348215135874: 111-49-2446E
• 09348215135867: 111-49-1454E
• 09348215135850: 111-49-1450E
• 09348215135843: 111-49-1446E