Origin NS Stem

GUDID 09348215087197

SIGNATURE ORTHOPAEDICS PTY LTD

Coated hip femur prosthesis, modular

• Primary Device ID: 09348215087197
• NIH Device Record Key: 54fb43fc-6e77-45b9-9604-0182da56d198
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Origin NS Stem
• Version Model Number: 111-23-5011
• 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	09348215087197 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102172

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-11
• Device Publish Date: 2021-10-01

On-Brand Devices [Origin NS Stem]

• 09348215087289: 111-23-5052
• 09348215087272: 111-23-5051
• 09348215087265: 111-23-5042
• 09348215087258: 111-23-5041
• 09348215087241: 111-23-5032
• 09348215087234: 111-23-5031
• 09348215087227: 111-23-5022
• 09348215087210: 111-23-5021
• 09348215087203: 111-23-5012
• 09348215087197: 111-23-5011
• 09348215087180: 111-23-5002
• 09348215087173: 111-23-5001