Logical 10d Face Changing Liner

GUDID 09348215139100

SIGNATURE ORTHOPAEDICS PTY LTD

Non-constrained polyethylene acetabular liner

• Primary Device ID: 09348215139100
• NIH Device Record Key: cb4e10ae-6427-4b7a-8213-968615d0ebdd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Logical 10d Face Changing Liner
• Version Model Number: 111-12-9310
• 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	09348215139100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241690

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 10d Face Changing Liner]

• 09348215139124: 111-12-9312
• 09348215139117: 111-12-9311
• 09348215139100: 111-12-9310
• 09348215139094: 111-12-9309
• 09348215139087: 111-12-9308
• 09348215139070: 111-12-9307
• 09348215139063: 111-12-9306
• 09348215139056: 111-12-9305
• 09348215139049: 111-12-9304
• 09348215139032: 111-12-9303
• 09348215139025: 111-12-9302
• 09348215139018: 111-12-9301