Logical Neutral Liner

GUDID 09348215094737

SIGNATURE ORTHOPAEDICS PTY LTD

Non-constrained polyethylene acetabular liner

• Primary Device ID: 09348215094737
• NIH Device Record Key: c9d5d934-e413-4f4e-8d9f-08615cbe26cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Logical Neutral Liner
• Version Model Number: 01-041-01-0236
• 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	09348215094737 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121297

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: 2022-03-18
• Device Publish Date: 2022-03-10

On-Brand Devices [Logical Neutral Liner]

• 09348215094782: 01-041-01-0540
• 09348215094768: 01-041-01-0440
• 09348215094751: 01-041-01-0536
• 09348215094744: 01-041-01-0436
• 09348215094737: 01-041-01-0236
• 09348215094706: 01-041-01-0232
• 09348215094690: 01-041-01-0132
• 09348215094676: 01-041-01-0128
• 09348215094669: 01-041-01-0028