Patella Trial

GUDID 09348215041809

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable

• Primary Device ID: 09348215041809
• NIH Device Record Key: e7e3bb8f-a2b8-4fdb-9b1e-a60242b9b0a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Patella Trial
• Version Model Number: 122-10-0247
• 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	09348215041809 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170613

FDA Product Code

• HWT: Template

Sterilization

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

[09348215041809]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-06-13
• Device Publish Date: 2018-09-24

On-Brand Devices [Patella Trial]

• 09348215041823: 122-10-0249
• 09348215041816: 122-10-0248
• 09348215041809: 122-10-0247
• 09348215041793: 122-10-0246
• 09348215064044: 122-18-0017
• 09348215064037: 122-18-0016
• 09348215064020: 122-18-0015
• 09348215064013: 122-18-0014
• 09348215064006: 122-18-0013
• 09348215063993: 122-18-0012
• 09348215063986: 122-18-0011