TriVerse I-Beam Osteotome

GUDID 09348215097493

SIGNATURE ORTHOPAEDICS PTY LTD

Orthopaedic osteotome

• Primary Device ID: 09348215097493
• NIH Device Record Key: 3d1a662f-5fcd-4527-838f-51a0033e46f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TriVerse I-Beam Osteotome
• Version Model Number: 122-22-0050
• 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	09348215097493 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222380

FDA Product Code

• HWM: Osteotome

Sterilization

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

[09348215097493]

Moist Heat or Steam Sterilization

[09348215097493]

Moist Heat or Steam Sterilization

[09348215097493]

Moist Heat or Steam Sterilization

[09348215097493]

Moist Heat or Steam Sterilization

[09348215097493]

Moist Heat or Steam Sterilization

[09348215097493]

Moist Heat or Steam Sterilization

[09348215097493]

Moist Heat or Steam Sterilization

[09348215097493]

Moist Heat or Steam Sterilization

[09348215097493]

Moist Heat or Steam Sterilization

[09348215097493]

Moist Heat or Steam Sterilization

[09348215097493]

Moist Heat or Steam Sterilization

[09348215097493]

Moist Heat or Steam Sterilization

[09348215097493]

Moist Heat or Steam Sterilization

[09348215097493]

Moist Heat or Steam Sterilization

[09348215097493]

Moist Heat or Steam Sterilization

[09348215097493]

Moist Heat or Steam Sterilization

[09348215097493]

Moist Heat or Steam Sterilization

[09348215097493]

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 I-Beam Osteotome]

• 09348215098223: 02-039-22-2201
• 09348215097493: 122-22-0050