Patella Drill Guide

GUDID 09348215041861

SIGNATURE ORTHOPAEDICS PTY LTD

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 09348215041861
• NIH Device Record Key: 0d6fe67f-9222-48b2-8d8d-6316da0ad8fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Patella Drill Guide
• Version Model Number: 122-10-0254
• Company DUNS: 751993028
• Company Name: SIGNATURE ORTHOPAEDICS PTY LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	09348215041861 [Primary]

FDA Product Code

• MDM: Instrument, Manual, Surgical, General Use

Sterilization

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

[09348215041861]

Moist Heat or Steam Sterilization

[09348215041861]

Moist Heat or Steam Sterilization

[09348215041861]

Moist Heat or Steam Sterilization

[09348215041861]

Moist Heat or Steam Sterilization

[09348215041861]

Moist Heat or Steam Sterilization

[09348215041861]

Moist Heat or Steam Sterilization

[09348215041861]

Moist Heat or Steam Sterilization

[09348215041861]

Moist Heat or Steam Sterilization

[09348215041861]

Moist Heat or Steam Sterilization

[09348215041861]

Moist Heat or Steam Sterilization

[09348215041861]

Moist Heat or Steam Sterilization

[09348215041861]

Moist Heat or Steam Sterilization

[09348215041861]

Moist Heat or Steam Sterilization

[09348215041861]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-05-03
• Device Publish Date: 2018-10-09

On-Brand Devices [Patella Drill Guide]

• 09348215074166: 122-15-0448
• 09348215041861: 122-10-0254
• 09348215041854: 122-10-0253
• 09348215041847: 122-10-0252
• 09348215041830: 122-10-0251
• 09348215117757: 122-18-1602