Logical Cup Liner - 10° Hood Vit-E

GUDID 09348215132897

SIGNATURE ORTHOPAEDICS PTY LTD

Non-constrained polyethylene acetabular liner

• Primary Device ID: 09348215132897
• NIH Device Record Key: 6c82e721-f186-4a0b-9b89-f81fb7c1373e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Logical Cup Liner - 10° Hood Vit-E
• Version Model Number: 111-12-6256E
• 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	09348215132897 [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 - 10° Hood Vit-E ]

• 09348215132958: 111-12-6460E
• 09348215132941: 111-12-6456E
• 09348215132934: 111-12-6660E
• 09348215132927: 111-12-6656E
• 09348215132910: 111-12-6652E
• 09348215132903: 111-12-6260E
• 09348215132897: 111-12-6256E
• 09348215132880: 111-12-6252E
• 09348215132873: 111-12-6250E
• 09348215132866: 111-12-6852E
• 09348215132859: 111-12-6850E
• 09348215132842: 111-12-6844E
• 09348215132835: 111-12-6240E