UTF Stem, reduced, Ti plasma spray, high offset 1106-3200

GUDID 04712771504941

UTF Stem, reduced, Ti plasma spray, high offset, #0

UNITED ORTHOPEDIC CORP.

Revision coated hip femur prosthesis

• Primary Device ID: 04712771504941
• NIH Device Record Key: 3fcce6d6-d910-4fc3-9d0b-9b54d052670d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UTF Stem, reduced, Ti plasma spray, high offset
• Version Model Number: 1106-3200
• Catalog Number: 1106-3200
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Customer Support Contacts

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

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04712771504941 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163193

FDA Product Code

• KWY: Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-08-06
• Device Publish Date: 2017-10-06

Devices Manufactured by UNITED ORTHOPEDIC CORP.

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• 04719886903980 - U2 Total Knee System: 2024-11-06 PS Notch cutting jig, #2
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• 04719886904000 - U2 Total Knee System: 2024-11-06 PS Notch cutting jig, #6
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• 04719886903546 - Resolve Modular Revision Stem: 2024-10-08 Proximal screw extractor, HEX 5
• 04719886903645 - U2 Total Knee System: 2024-10-08 Tibial cutting jig, open slot, 0°, left