SignaSure Trial Shell

GUDID 09348215084554

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable

• Primary Device ID: 09348215084554
• NIH Device Record Key: 45fb7d5e-d74d-4771-a447-917f1cb80ea7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SignaSure Trial Shell
• Version Model Number: 112-35-0460
• 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	09348215084554 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211742

FDA Product Code

• HWT: Template

Sterilization

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

[09348215084554]

Moist Heat or Steam Sterilization

[09348215084554]

Moist Heat or Steam Sterilization

[09348215084554]

Moist Heat or Steam Sterilization

[09348215084554]

Moist Heat or Steam Sterilization

[09348215084554]

Moist Heat or Steam Sterilization

[09348215084554]

Moist Heat or Steam Sterilization

[09348215084554]

Moist Heat or Steam Sterilization

[09348215084554]

Moist Heat or Steam Sterilization

[09348215084554]

Moist Heat or Steam Sterilization

[09348215084554]

Moist Heat or Steam Sterilization

[09348215084554]

Moist Heat or Steam Sterilization

[09348215084554]

Moist Heat or Steam Sterilization

[09348215084554]

Moist Heat or Steam Sterilization

[09348215084554]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-07
• Device Publish Date: 2022-01-28

On-Brand Devices [SignaSure Trial Shell]

• 09348215084578: 112-35-0464
• 09348215084561: 112-35-0462
• 09348215084554: 112-35-0460
• 09348215084547: 112-35-0458
• 09348215084530: 112-35-0456
• 09348215084523: 112-35-0454
• 09348215084516: 112-35-0452
• 09348215084509: 112-35-0450
• 09348215084493: 112-35-0448
• 09348215084486: 112-35-0446
• 09348215084479: 112-35-0444
• 09348215084462: 112-35-0442