SignaSure Trial Poly

GUDID 09348215079949

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable

• Primary Device ID: 09348215079949
• NIH Device Record Key: f0f6acb5-a447-491f-94df-56eca4c9ee1f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SignaSure Trial Poly
• Version Model Number: 112-35-0242
• 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	09348215079949 [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

[09348215079949]

Moist Heat or Steam Sterilization

[09348215079949]

Moist Heat or Steam Sterilization

[09348215079949]

Moist Heat or Steam Sterilization

[09348215079949]

Moist Heat or Steam Sterilization

[09348215079949]

Moist Heat or Steam Sterilization

[09348215079949]

Moist Heat or Steam Sterilization

[09348215079949]

Moist Heat or Steam Sterilization

[09348215079949]

Moist Heat or Steam Sterilization

[09348215079949]

Moist Heat or Steam Sterilization

[09348215079949]

Moist Heat or Steam Sterilization

[09348215079949]

Moist Heat or Steam Sterilization

[09348215079949]

Moist Heat or Steam Sterilization

[09348215079949]

Moist Heat or Steam Sterilization

[09348215079949]

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 Poly]

• 09348215080099: 112-35-0264
• 09348215080082: 112-35-0262
• 09348215080075: 112-35-0260
• 09348215080068: 112-35-0258
• 09348215080051: 112-35-0256
• 09348215080044: 112-35-0254
• 09348215080037: 112-35-0252
• 09348215080013: 112-35-0250
• 09348215079994: 112-35-0248
• 09348215079987: 112-35-0247
• 09348215079970: 112-35-0245
• 09348215079949: 112-35-0242
• 09348215083519: 112-35-0243
• 09348215079918: 112-35-0267