Aria Reduced Distal

GUDID 09348215032012

SIGNATURE ORTHOPAEDICS PTY LTD

Coated hip femur prosthesis, modular

• Primary Device ID: 09348215032012
• NIH Device Record Key: a26d1215-5c2a-4ac2-80cb-dc97619c567b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aria Reduced Distal
• Version Model Number: 111-20-6405
• 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	09348215032012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121297

FDA Product Code

• LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

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: 2019-09-24
• Device Publish Date: 2019-09-16

On-Brand Devices [Aria Reduced Distal]

• 09348215055318: 111-20-6400
• 09348215055301: 111-20-6300
• 09348215055295: 111-20-6402
• 09348215055288: 111-20-6401
• 09348215055271: 111-20-6302
• 09348215055264: 111-20-6301
• 09348215032081: 111-20-6412
• 09348215032074: 111-20-6411
• 09348215032067: 111-20-6410
• 09348215032050: 111-20-6409
• 09348215032043: 111-20-6408
• 09348215032036: 111-20-6407
• 09348215032029: 111-20-6406
• 09348215032012: 111-20-6405
• 09348215032005: 111-20-6404
• 09348215031992: 111-20-6403