World Cup Liner - 10° Hood Vit-E

GUDID 09348215134105

SIGNATURE ORTHOPAEDICS PTY LTD

Non-constrained polyethylene acetabular liner

• Primary Device ID: 09348215134105
• NIH Device Record Key: 420489da-dd70-44a6-8ae1-b35e60227d71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: World Cup Liner - 10° Hood Vit-E
• Version Model Number: 111-49-3148E
• 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	09348215134105 [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 - 10° Hood Vit-E ]

• 09348215134105: 111-49-3148E
• 09348215133962: 111-49-4158E
• 09348215133955: 111-49-4154E
• 09348215133948: 111-49-3158E
• 09348215133931: 111-49-3154E
• 09348215133924: 111-49-3150E
• 09348215133917: 111-49-2158E
• 09348215133900: 111-49-2154E
• 09348215133894: 111-49-2150E
• 09348215133887: 111-49-2146E
• 09348215133870: 111-49-1154E
• 09348215133863: 111-49-1150E
• 09348215133856: 111-49-1146E