U1 Total Hip System, Femoral head 1201-1522

GUDID 04712602341516

U1 Hip System, Femoral head, OD22mm, +6mm

UNITED ORTHOPEDIC CORP.

Femoral head bipolar component

• Primary Device ID: 04712602341516
• NIH Device Record Key: 2f9a8f20-4278-42ab-b281-e60c46ea69dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U1 Total Hip System, Femoral head
• Version Model Number: 1201-1522
• Catalog Number: 1201-1522
• 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
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04712602341516 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152439

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: 2018-08-02
• Device Publish Date: 2016-06-06

On-Brand Devices [U1 Total Hip System, Femoral head]

• 04712602341530: U1 Hip System, Femoral head, OD22mm, +9mm
• 04712602341516: U1 Hip System, Femoral head, OD22mm, +6mm