Trial Sleeve Assembly

GUDID 09348215038243

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable

• Primary Device ID: 09348215038243
• NIH Device Record Key: b7901339-15d3-4bb9-8332-b4dac3106bba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trial Sleeve Assembly
• Version Model Number: 112-33-0061
• 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	09348215038243 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143184

FDA Product Code

• HWT: Template
• KWL: Prosthesis, Hip, Hemi-, Femoral, Metal

Sterilization

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

[09348215038243]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-06-18
• Device Publish Date: 2018-10-05

On-Brand Devices [Trial Sleeve Assembly]

• 09348215038267: 112-33-0063
• 09348215038250: 112-33-0062
• 09348215038243: 112-33-0061
• 09348215038236: 112-33-0060