Logical 10d Face Changing Liner Vit-E

GUDID 09348215133658

SIGNATURE ORTHOPAEDICS PTY LTD

Non-constrained polyethylene acetabular liner

• Primary Device ID: 09348215133658
• NIH Device Record Key: 496b1704-dce9-48c3-b7d2-673ee1863e25
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Logical 10d Face Changing Liner Vit-E
• Version Model Number: 111-12-9305E
• 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	09348215133658 [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 Vit-E]

• 09348215133726: 111-12-9312E
• 09348215133719: 111-12-9311E
• 09348215133702: 111-12-9310E
• 09348215133696: 111-12-9309E
• 09348215133689: 111-12-9308E
• 09348215133672: 111-12-9307E
• 09348215133665: 111-12-9306E
• 09348215133658: 111-12-9305E
• 09348215133641: 111-12-9304E
• 09348215133634: 111-12-9303E
• 09348215133627: 111-12-9302E
• 09348215133610: 111-12-9301E