TSI Stem Trial

GUDID 09348215040598

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable Surgical implant template, reusable

• Primary Device ID: 09348215040598
• NIH Device Record Key: 194a8b43-d328-483c-a140-f6d80e66d958
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TSI Stem Trial
• Version Model Number: 111-23-3040
• 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	09348215040598 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181340

FDA Product Code

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

Sterilization

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

[09348215040598]

Moist Heat or Steam Sterilization

[09348215040598]

Moist Heat or Steam Sterilization

[09348215040598]

Moist Heat or Steam Sterilization

[09348215040598]

Moist Heat or Steam Sterilization

[09348215040598]

Moist Heat or Steam Sterilization

[09348215040598]

Moist Heat or Steam Sterilization

[09348215040598]

Moist Heat or Steam Sterilization

[09348215040598]

Moist Heat or Steam Sterilization

[09348215040598]

Moist Heat or Steam Sterilization

[09348215040598]

Moist Heat or Steam Sterilization

[09348215040598]

Moist Heat or Steam Sterilization

[09348215040598]

Moist Heat or Steam Sterilization

[09348215040598]

Moist Heat or Steam Sterilization

[09348215040598]

Moist Heat or Steam Sterilization

[09348215040598]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-06-18
• Device Publish Date: 2018-10-02

On-Brand Devices [TSI Stem Trial]

• 09348215040604: 111-23-3050
• 09348215040598: 111-23-3040
• 09348215040581: 111-23-3030
• 09348215040574: 111-23-3020
• 09348215040567: 111-23-3010
• 09348215040550: 111-23-3000