TriVerse Tibial Tray

GUDID 09348215110178

SIGNATURE ORTHOPAEDICS PTY LTD

Instrument tray, reusable

• Primary Device ID: 09348215110178
• NIH Device Record Key: 043dbe8e-f25c-4d6f-bbfc-009fb1ddaf43
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TriVerse Tibial Tray
• Version Model Number: 02-039-01-0030
• 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	09348215110178 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222380

FDA Product Code

• FSM: Tray, Surgical, Instrument

Sterilization

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

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 Tibial Tray]

• 09348215110192: 02-039-01-0020
• 09348215110185: 02-039-01-0010
• 09348215110178: 02-039-01-0030
• 09348215108946: 122-22-9300
• 09348215108939: 122-22-9200
• 09348215108922: 122-22-9000