Logical Lateralised Liner – Neutral Vit-E

GUDID 09348215133207

SIGNATURE ORTHOPAEDICS PTY LTD

Non-constrained polyethylene acetabular liner

• Primary Device ID: 09348215133207
• NIH Device Record Key: 28dd8107-5082-45c7-98e9-e4a69787cefe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Logical Lateralised Liner – Neutral Vit-E
• Version Model Number: 111-12-7456E
• 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	09348215133207 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121297

FDA Product Code

• LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

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 – Neutral Vit-E ]

• 09348215133214: 111-12-7460E
• 09348215133207: 111-12-7456E
• 09348215133191: 111-12-7660E
• 09348215133184: 111-12-7656E
• 09348215133177: 111-12-7652E
• 09348215133160: 111-12-7260E
• 09348215133153: 111-12-7256E
• 09348215133146: 111-12-7252E
• 09348215133139: 111-12-7250E
• 09348215133122: 111-12-7852E
• 09348215133115: 111-12-7850E
• 09348215133108: 111-12-7844E
• 09348215133092: 111-12-7240E