UTF stem, reduced, Ti plasma spray 1106-3099

GUDID 04712771505207

UTF Stem, reduced, Ti plasma spray, #00

UNITED ORTHOPEDIC CORP.

Coated hip femur prosthesis, modular

• Primary Device ID: 04712771505207
• NIH Device Record Key: af4438c3-2ae9-4171-b862-df987c0e0bd4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UTF stem, reduced, Ti plasma spray
• Version Model Number: 1106-3099
• Catalog Number: 1106-3099
• 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	04712771505207 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163193

FDA Product Code

• LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, 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

On-Brand Devices [UTF stem, reduced, Ti plasma spray]

• 04712771505207: UTF Stem, reduced, Ti plasma spray, #00
• 04712771505078: UTF stem, reduced, Ti plasma spray, #0