Evolve Distal Centraliser

GUDID 09348215053772

SIGNATURE ORTHOPAEDICS PTY LTD

Femoral stem centralizer

• Primary Device ID: 09348215053772
• NIH Device Record Key: cb5145d9-9b0e-4405-a53f-7719b2c9321d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Evolve Distal Centraliser
• Version Model Number: D111-162-003
• 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	09348215053772 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133370

FDA Product Code

• JDI: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-28
• Device Publish Date: 2022-09-20

On-Brand Devices [Evolve Distal Centraliser]

• 09348215053772: D111-162-003
• 09348215053765: D111-162-002