TSI Trial Neck

GUDID 09348215040536

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable

• Primary Device ID: 09348215040536
• NIH Device Record Key: f60fa257-238a-4a6a-8cb9-0c4eed1f017f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TSI Trial Neck
• Version Model Number: 111-23-2008
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	09348215040536 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181340

FDA Product Code

• JDI: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[09348215040536]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-06-17
• Device Publish Date: 2018-10-02

On-Brand Devices [TSI Trial Neck]

• 09348215040543: 111-23-2009
• 09348215040536: 111-23-2008