TriVerse Femoral Trial

GUDID 09348215098452

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable

• Primary Device ID: 09348215098452
• NIH Device Record Key: 2f8d7191-0358-4bdd-8e81-1f10bf9a68ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TriVerse Femoral Trial
• Version Model Number: 02-039-15-1075
• 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	09348215098452 [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

[09348215098452]

Moist Heat or Steam Sterilization

[09348215098452]

Moist Heat or Steam Sterilization

[09348215098452]

Moist Heat or Steam Sterilization

[09348215098452]

Moist Heat or Steam Sterilization

[09348215098452]

Moist Heat or Steam Sterilization

[09348215098452]

Moist Heat or Steam Sterilization

[09348215098452]

Moist Heat or Steam Sterilization

[09348215098452]

Moist Heat or Steam Sterilization

[09348215098452]

Moist Heat or Steam Sterilization

[09348215098452]

Moist Heat or Steam Sterilization

[09348215098452]

Moist Heat or Steam Sterilization

[09348215098452]

Moist Heat or Steam Sterilization

[09348215098452]

Moist Heat or Steam Sterilization

[09348215098452]

Moist Heat or Steam Sterilization

[09348215098452]

Moist Heat or Steam Sterilization

[09348215098452]

Moist Heat or Steam Sterilization

[09348215098452]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-02-27
• Device Publish Date: 2023-02-17

On-Brand Devices [TriVerse Femoral Trial]

• 09348215098469: 02-039-15-1080
• 09348215098452: 02-039-15-1075
• 09348215098445: 02-039-15-1072
• 09348215098438: 02-039-15-1070
• 09348215098421: 02-039-15-1067
• 09348215098414: 02-039-15-1065
• 09348215098407: 02-039-15-1062
• 09348215098391: 02-039-15-1060
• 09348215098384: 02-039-15-1057
• 09348215098377: 02-039-15-1055
• 09348215097929: 122-22-0180
• 09348215097912: 122-22-0175
• 09348215097905: 122-22-0172
• 09348215097899: 122-22-0170
• 09348215097882: 122-22-0167
• 09348215097875: 122-22-0165
• 09348215097868: 122-22-0162
• 09348215097851: 122-22-0160
• 09348215097844: 122-22-0157
• 09348215097837: 122-22-0155