United Hip System, UTF Stem, Ti Plasma Spray, High 1106-1219

GUDID 04712771495737

UTF stem, Ti plasma spray, high offset, #19

UNITED ORTHOPEDIC CORP.

Revision coated hip femur prosthesis

• Primary Device ID: 04712771495737
• NIH Device Record Key: 506889b6-df31-4023-8b3d-308a8886b0c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: United Hip System, UTF Stem, Ti Plasma Spray, High
• Version Model Number: 1106-1219
• Catalog Number: 1106-1219
• 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	04712771495737 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110245

FDA Product Code

• LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, 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: 2015-10-24

On-Brand Devices [United Hip System, UTF Stem, Ti Plasma Spray, High]

• 04712771495744: UTF stem, Ti plasma spray, high offset, #22
• 04712771495737: UTF stem, Ti plasma spray, high offset, #19
• 04712771495720: UTF stem, Ti plasma spray, high offset, #16.5
• 04712771495713: UTF stem, Ti plasma spray, high offset, #14.5
• 04712771495706: UTF stem, Ti plasma spray, high offset, #13
• 04712771495690: UTF stem, Ti plasma spray, high offset, #12
• 04712771495683: UTF stem, Ti plasma spray, high offset, #11
• 04712771495676: UTF stem, Ti plasma spray, high offset, #10
• 04712771495669: UTF stem, Ti plasma spray, high offset, #9
• 04712771495652: UTF stem, Ti plasma spray, high offset, #7.5