Tibial Trial Tray

GUDID 09348215062095

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable

• Primary Device ID: 09348215062095
• NIH Device Record Key: c36e4615-3eec-4f5e-825a-7be876c4b95e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tibial Trial Tray
• Version Model Number: 122-18-0318
• 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	09348215062095 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190577

FDA Product Code

• HWT: Template

Sterilization

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

[09348215062095]

Moist Heat or Steam Sterilization

[09348215062095]

Moist Heat or Steam Sterilization

[09348215062095]

Moist Heat or Steam Sterilization

[09348215062095]

Moist Heat or Steam Sterilization

[09348215062095]

Moist Heat or Steam Sterilization

[09348215062095]

Moist Heat or Steam Sterilization

[09348215062095]

Moist Heat or Steam Sterilization

[09348215062095]

Moist Heat or Steam Sterilization

[09348215062095]

Moist Heat or Steam Sterilization

[09348215062095]

Moist Heat or Steam Sterilization

[09348215062095]

Moist Heat or Steam Sterilization

[09348215062095]

Moist Heat or Steam Sterilization

[09348215062095]

Moist Heat or Steam Sterilization

[09348215062095]

Moist Heat or Steam Sterilization

[09348215062095]

Moist Heat or Steam Sterilization

[09348215062095]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-06-11
• Device Publish Date: 2020-06-03

On-Brand Devices [Tibial Trial Tray]

• 09348215062101: 122-18-0319
• 09348215062095: 122-18-0318
• 09348215062088: 122-18-0317
• 09348215062071: 122-18-0316
• 09348215062064: 122-18-0315
• 09348215062057: 122-18-0314
• 09348215062040: 122-18-0313
• 09348215062033: 122-18-0312
• 09348215062026: 122-18-0311
• 09348215062019: 122-18-0310