Fusion Ceramic Head 32mm

GUDID 09348215007843

SIGNATURE ORTHOPAEDICS PTY LTD

Ceramic femoral head prosthesis

• Primary Device ID: 09348215007843
• NIH Device Record Key: c6bfa8bb-37a8-4bf4-a44e-79abead72aec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fusion Ceramic Head 32mm
• Version Model Number: 111-22-0512
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	09348215007843 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201047

FDA Product Code

• MEH: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-06-23
• Device Publish Date: 2021-04-23

On-Brand Devices [Fusion Ceramic Head 32mm]

• 09348215080921: 111-22-0512
• 09348215007843: 111-22-0512