Logical Lateralised Liner – 20° Hood Vit-E

GUDID 09348215133436

SIGNATURE ORTHOPAEDICS PTY LTD

Non-constrained polyethylene acetabular liner

• Primary Device ID: 09348215133436
• NIH Device Record Key: cee3eaa4-647b-4242-b9bd-5dba1d452225
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Logical Lateralised Liner – 20° Hood Vit-E
• Version Model Number: 111-12-9652E
• 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	09348215133436 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153131

FDA Product Code

• MEH: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-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: 2024-10-11
• Device Publish Date: 2024-10-03

On-Brand Devices [Logical Lateralised Liner – 20° Hood Vit-E ]

• 09348215133474: 111-12-9460E
• 09348215133467: 111-12-9456E
• 09348215133450: 111-12-9660E
• 09348215133443: 111-12-9656E
• 09348215133436: 111-12-9652E
• 09348215133429: 111-12-9260E
• 09348215133412: 111-12-9256E
• 09348215133405: 111-12-9252E
• 09348215133399: 111-12-9250E
• 09348215133382: 111-12-9852E
• 09348215133375: 111-12-9850E
• 09348215133368: 111-12-9844E
• 09348215133351: 111-12-9240E