Logical Constrained Liner

GUDID 09348215054489

SIGNATURE ORTHOPAEDICS PTY LTD

Constrained polyethylene acetabular liner

• Primary Device ID: 09348215054489
• NIH Device Record Key: 7d3b20ba-197d-492d-85b0-b6f84cbb70b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Logical Constrained Liner
• Version Model Number: D111-12-9203
• 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	09348215054489 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153131

FDA Product Code

• KWZ: Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer

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: 2022-09-28
• Device Publish Date: 2022-09-20

On-Brand Devices [Logical Constrained Liner]

• 09348215095420: 01-041-07-0540
• 09348215095413: 01-041-07-0436
• 09348215095406: 01-041-07-0232
• 09348215095390: 01-041-07-0128
• 09348215054496: D111-12-9204
• 09348215054489: D111-12-9203
• 09348215054472: D111-12-9202
• 09348215054465: D111-12-9201