U1 Hip System, Bipolar Cup Liner 1601-1062

GUDID 04711605564939

U1 Bipolar cap liner,62mm

UNITED ORTHOPEDIC CORP.

Femoral head bipolar component

• Primary Device ID: 04711605564939
• NIH Device Record Key: 492bf7c2-745c-4c8e-ba09-31be2aff8d45
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U1 Hip System, Bipolar Cup Liner
• Version Model Number: 1601-1062
• Catalog Number: 1601-1062
• 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: 62 Millimeter
• Outer Diameter: 62 Millimeter
• Outer Diameter: 62 Millimeter
• Outer Diameter: 62 Millimeter
• Outer Diameter: 62 Millimeter
• Outer Diameter: 62 Millimeter
• Outer Diameter: 62 Millimeter
• Outer Diameter: 62 Millimeter
• Outer Diameter: 62 Millimeter
• Outer Diameter: 62 Millimeter
• Outer Diameter: 62 Millimeter
• Outer Diameter: 62 Millimeter
• Outer Diameter: 62 Millimeter
• Outer Diameter: 62 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04711605564939 [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 Liner]

• 04712602344432: U1 Bipolar cap liner,56mm
• 04712602344425: U1 Bipolar cap liner,55mm
• 04712602344418: U1 Bipolar cap liner,54mm
• 04712602344401: U1 Bipolar cap liner,53mm
• 04711605564939: U1 Bipolar cap liner,62mm
• 04711605564922: U1 Bipolar cap liner,61mm
• 04711605564915: U1 Bipolar cap liner,60mm
• 04711605564908: U1 Bipolar cap liner,59mm
• 04711605564892: U1 Bipolar cap liner,58mm
• 04711605564885: U1 Bipolar cap liner,57mm