Lateralised Neutral Trial Liner : SIZE 36/60-68mm

GUDID 09348215057190

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable

• Primary Device ID: 09348215057190
• NIH Device Record Key: da8b58a8-31d7-4ad9-90ce-c9c5e4617b5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lateralised Neutral Trial Liner : SIZE 36/60-68mm
• Version Model Number: 112-15-7660
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	09348215057190 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121297

FDA Product Code

• HWT: Template

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[09348215057190]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-13
• Device Publish Date: 2019-11-05

Devices Manufactured by SIGNATURE ORTHOPAEDICS PTY LTD

• 09348215092832 - Origin Complete Lateral Offset Collarless Cementless: 2025-01-01
• 09348215092849 - Origin Complete Lateral Offset Collarless Cementless: 2025-01-01
• 09348215092856 - Origin Complete Lateral Offset Collarless Cementless: 2025-01-01
• 09348215092863 - Origin Complete Lateral Offset Collarless Cementless: 2025-01-01
• 09348215092870 - Origin Complete Lateral Offset Collarless Cementless: 2025-01-01
• 09348215092887 - Origin Complete Lateral Offset Collarless Cementless: 2025-01-01
• 09348215092894 - Origin Complete Lateral Offset Collarless Cementless: 2025-01-01
• 09348215092900 - Origin Complete Lateral Offset Collarless Cementless: 2025-01-01