United Hip System, UTF Stem, Ti Plasma Spray 1106-1012

GUDID 04712771495591

UTF stem, Ti plasma spray, #12

UNITED ORTHOPEDIC CORP.

Revision coated hip femur prosthesis

• Primary Device ID: 04712771495591
• NIH Device Record Key: c9bf8fb9-a476-4980-88f5-46f069bce0c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: United Hip System, UTF Stem, Ti Plasma Spray
• Version Model Number: 1106-1012
• Catalog Number: 1106-1012
• 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	04712771495591 [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]

• 04712771495645: UTF stem, Ti plasma spray, #22
• 04712771495638: UTF stem, Ti plasma spray, #19
• 04712771495621: UTF stem, Ti plasma spray, #16.5
• 04712771495614: UTF stem, Ti plasma spray, #14.5
• 04712771495607: UTF stem, Ti plasma spray, #13
• 04712771495591: UTF stem, Ti plasma spray, #12
• 04712771495584: UTF stem, Ti plasma spray, #11
• 04712771495577: UTF stem, Ti plasma spray, #10
• 04712771495560: UTF stem, Ti plasma spray, #9
• 04712771495553: UTF stem, Ti plasma spray, #7.5