U1 Hip System, Bipolar Cup 1501-1054

GUDID 04712602343954

U1 Bipolar cap,54mm

UNITED ORTHOPEDIC CORP.

Femoral head bipolar component

• Primary Device ID: 04712602343954
• NIH Device Record Key: daf4d2e8-f1e3-45b3-b984-33ddf69a074e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U1 Hip System, Bipolar Cup
• Version Model Number: 1501-1054
• Catalog Number: 1501-1054
• 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

• Outer Diameter: 54 Millimeter
• Outer Diameter: 54 Millimeter
• Outer Diameter: 54 Millimeter
• Outer Diameter: 54 Millimeter
• Outer Diameter: 54 Millimeter
• Outer Diameter: 54 Millimeter
• Outer Diameter: 54 Millimeter
• Outer Diameter: 54 Millimeter
• Outer Diameter: 54 Millimeter
• Outer Diameter: 54 Millimeter
• Outer Diameter: 54 Millimeter
• Outer Diameter: 54 Millimeter
• Outer Diameter: 54 Millimeter
• Outer Diameter: 54 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04712602343954 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050269

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: 2015-10-24

On-Brand Devices [U1 Hip System, Bipolar Cup]

• 04712602343978: U1 Bipolar cap,56mm
• 04712602343961: U1 Bipolar cap,55mm
• 04712602343954: U1 Bipolar cap,54mm
• 04712602343947: U1 Bipolar cap,53mm
• 04711605564878: U1 Bipolar cap,62mm
• 04711605564861: U1 Bipolar cap,61mm
• 04711605564854: U1 Bipolar cap,60mm
• 04711605564847: U1 Bipolar cap,59mm
• 04711605564830: U1 Bipolar cap,58mm
• 04711605564823: U1 Bipolar cap,57mm