TriVerse Modular Tray Trial

GUDID 09348215098612

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable

• Primary Device ID: 09348215098612
• NIH Device Record Key: c8003385-1e42-433d-ae72-4f46e073b1af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TriVerse Modular Tray Trial
• Version Model Number: 02-039-25-1075
• 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: true
• 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	09348215098612 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222380

FDA Product Code

• HWT: Template

Sterilization

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

[09348215098612]

Moist Heat or Steam Sterilization

[09348215098612]

Moist Heat or Steam Sterilization

[09348215098612]

Moist Heat or Steam Sterilization

[09348215098612]

Moist Heat or Steam Sterilization

[09348215098612]

Moist Heat or Steam Sterilization

[09348215098612]

Moist Heat or Steam Sterilization

[09348215098612]

Moist Heat or Steam Sterilization

[09348215098612]

Moist Heat or Steam Sterilization

[09348215098612]

Moist Heat or Steam Sterilization

[09348215098612]

Moist Heat or Steam Sterilization

[09348215098612]

Moist Heat or Steam Sterilization

[09348215098612]

Moist Heat or Steam Sterilization

[09348215098612]

Moist Heat or Steam Sterilization

[09348215098612]

Moist Heat or Steam Sterilization

[09348215098612]

Moist Heat or Steam Sterilization

[09348215098612]

Moist Heat or Steam Sterilization

[09348215098612]

Moist Heat or Steam Sterilization

[09348215098612]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-02-28
• Device Publish Date: 2023-02-20

On-Brand Devices [TriVerse Modular Tray Trial]

• 09348215098650: 02-039-25-1091
• 09348215098643: 02-039-25-1087
• 09348215098636: 02-039-25-1083
• 09348215098629: 02-039-25-1079
• 09348215098612: 02-039-25-1075
• 09348215098605: 02-039-25-1071
• 09348215098599: 02-039-25-1067
• 09348215098582: 02-039-25-1063
• 09348215098575: 02-039-25-1059
• 09348215097721: 122-22-3091
• 09348215097714: 122-22-3087
• 09348215097707: 122-22-3083
• 09348215097691: 122-22-3079
• 09348215097684: 122-22-3075
• 09348215097677: 122-22-3071
• 09348215097660: 122-22-3067
• 09348215097653: 122-22-3063
• 09348215097646: 122-22-3059