Logical G-Series Cup Shell - Multi Hole

GUDID 09348215094539

SIGNATURE ORTHOPAEDICS PTY LTD

Acetabular shell

• Primary Device ID: 09348215094539
• NIH Device Record Key: 1b643402-2390-49c8-bf48-93ab6469e8ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Logical G-Series Cup Shell - Multi Hole
• Version Model Number: 01-040-02-0148
• 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	09348215094539 [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: 2023-11-27
• Device Publish Date: 2023-11-17

On-Brand Devices [Logical G-Series Cup Shell - Multi Hole]

• 09348215094546: 01-040-02-0150
• 09348215094539: 01-040-02-0148