Logical Dual Mobility Poly Insert

GUDID 09348215112431

SIGNATURE ORTHOPAEDICS PTY LTD

Non-constrained polyethylene acetabular liner

• Primary Device ID: 09348215112431
• NIH Device Record Key: 38da17d6-d623-4f2e-8300-af87b94d1c2b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Logical Dual Mobility Poly Insert
• Version Model Number: 01-042-02-2238
• 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	09348215112431 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220495

FDA Product Code

• MEH: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium 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: 2023-03-21
• Device Publish Date: 2023-03-13

On-Brand Devices [Logical Dual Mobility Poly Insert]

• 09348215112462: 01-042-02-2848
• 09348215112455: 01-042-02-2845
• 09348215112448: 01-042-02-2841
• 09348215112431: 01-042-02-2238
• 09348215112424: 01-042-02-2234