Evolve Distal Centraliser

GUDID 09348215053772

SIGNATURE ORTHOPAEDICS PTY LTD

Femoral stem centralizer Femoral stem centralizer Femoral stem centralizer Femoral stem centralizer Femoral stem centralizer Femoral stem centralizer Femoral stem centralizer Femoral stem centralizer Femoral stem centralizer Femoral stem centralizer Femoral stem centralizer Femoral stem centralizer Femoral stem centralizer Femoral stem centralizer 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