Logical Cup Liner – Neutral Vit-E

GUDID 09348215132767

SIGNATURE ORTHOPAEDICS PTY LTD

Non-constrained polyethylene acetabular liner

• Primary Device ID: 09348215132767
• NIH Device Record Key: 1cc5b9dc-6ad9-4a63-99e3-00abf993894b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Logical Cup Liner – Neutral Vit-E
• Version Model Number: 111-12-5256E
• 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	09348215132767 [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 Cup Liner – Neutral Vit-E ]

• 09348215132828: 111-12-5460E
• 09348215132811: 111-12-5456E
• 09348215132804: 111-12-5660E
• 09348215132798: 111-12-5656E
• 09348215132781: 111-12-5652E
• 09348215132774: 111-12-5260E
• 09348215132767: 111-12-5256E
• 09348215132750: 111-12-5252E
• 09348215132743: 111-12-5250E
• 09348215132736: 111-12-5852E
• 09348215132729: 111-12-5850E
• 09348215132712: 111-12-5844E
• 09348215132705: 111-12-5240E