World Knee Tibial Monotrial - UC

GUDID 09348215081195

SIGNATURE ORTHOPAEDICS PTY LTD

Surgical implant template, reusable

• Primary Device ID: 09348215081195
• NIH Device Record Key: fc304ff9-2eb1-478c-b8cb-768aa3d0f6a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: World Knee Tibial Monotrial - UC
• Version Model Number: 122-18-0588
• 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	09348215081195 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181530

FDA Product Code

• HWT: Template

Sterilization

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

[09348215081195]

Moist Heat or Steam Sterilization

[09348215081195]

Moist Heat or Steam Sterilization

[09348215081195]

Moist Heat or Steam Sterilization

[09348215081195]

Moist Heat or Steam Sterilization

[09348215081195]

Moist Heat or Steam Sterilization

[09348215081195]

Moist Heat or Steam Sterilization

[09348215081195]

Moist Heat or Steam Sterilization

[09348215081195]

Moist Heat or Steam Sterilization

[09348215081195]

Moist Heat or Steam Sterilization

[09348215081195]

Moist Heat or Steam Sterilization

[09348215081195]

Moist Heat or Steam Sterilization

[09348215081195]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-05
• Device Publish Date: 2021-02-25

On-Brand Devices [World Knee Tibial Monotrial - UC ]

• 09348215081225: 122-18-0591
• 09348215081218: 122-18-0590
• 09348215081201: 122-18-0589
• 09348215081195: 122-18-0588
• 09348215081188: 122-18-0587
• 09348215081171: 122-18-0586
• 09348215081164: 122-18-0585
• 09348215081157: 122-18-0584
• 09348215081140: 122-18-0583