USTAR II Knee System

GUDID 04711605588812

Tibial augment trial, #6, 5mm, left

UNITED ORTHOPEDIC CORP.

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• Primary Device ID: 04711605588812
• NIH Device Record Key: bbbd2a46-61ea-455b-8dc5-3cbc994c61de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: USTAR II Knee System
• Version Model Number: 2815-2161
• Company DUNS: 656700556
• Company Name: UNITED ORTHOPEDIC CORP.
• 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: true
• 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

Customer Support Contacts

• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw
• Phone: +886229294567
• Email: service@uoc.com.tw

Device Identifiers

Device Issuing Agency	Device ID
GS1	04711605588812 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190100

FDA Product Code

• KWL: Prosthesis, Hip, Hemi-, Femoral, Metal

Sterilization

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

[04711605588812]

Moist Heat or Steam Sterilization

[04711605588812]

Moist Heat or Steam Sterilization

[04711605588812]

Moist Heat or Steam Sterilization

[04711605588812]

Moist Heat or Steam Sterilization

[04711605588812]

Moist Heat or Steam Sterilization

[04711605588812]

Moist Heat or Steam Sterilization

[04711605588812]

Moist Heat or Steam Sterilization

[04711605588812]

Moist Heat or Steam Sterilization

[04711605588812]

Moist Heat or Steam Sterilization

[04711605588812]

Moist Heat or Steam Sterilization

[04711605588812]

Moist Heat or Steam Sterilization

[04711605588812]

Moist Heat or Steam Sterilization

[04711605588812]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-03
• Device Publish Date: 2019-12-26

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