TriVerse Asymmetric Patella Trial

GUDID 09348215109691

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable

• Primary Device ID: 09348215109691
• NIH Device Record Key: 9d4e3f86-b9e0-41a7-a0e7-f1c5a47472db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TriVerse Asymmetric Patella Trial
• Version Model Number: 02-039-33-2862
• 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	09348215109691 [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

[09348215109691]

Moist Heat or Steam Sterilization

[09348215109691]

Moist Heat or Steam Sterilization

[09348215109691]

Moist Heat or Steam Sterilization

[09348215109691]

Moist Heat or Steam Sterilization

[09348215109691]

Moist Heat or Steam Sterilization

[09348215109691]

Moist Heat or Steam Sterilization

[09348215109691]

Moist Heat or Steam Sterilization

[09348215109691]

Moist Heat or Steam Sterilization

[09348215109691]

Moist Heat or Steam Sterilization

[09348215109691]

Moist Heat or Steam Sterilization

[09348215109691]

Moist Heat or Steam Sterilization

[09348215109691]

Moist Heat or Steam Sterilization

[09348215109691]

Moist Heat or Steam Sterilization

[09348215109691]

Moist Heat or Steam Sterilization

[09348215109691]

Moist Heat or Steam Sterilization

[09348215109691]

Moist Heat or Steam Sterilization

[09348215109691]

Moist Heat or Steam Sterilization

[09348215109691]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-01
• Device Publish Date: 2023-02-21

On-Brand Devices [TriVerse Asymmetric Patella Trial]

• 09348215109738: 02-039-33-3710
• 09348215109721: 02-039-33-3485
• 09348215109714: 02-039-33-3180
• 09348215109707: 02-039-33-3162
• 09348215109691: 02-039-33-2862
• 09348215098346: 122-22-2862
• 09348215097639: 122-22-3710
• 09348215097622: 122-22-3485
• 09348215097615: 122-22-3180
• 09348215097608: 122-22-3162