U1 Hip System, Bipolar Cup Liner 1601-1053

GUDID 04712602344401

U1 Bipolar cap liner,53mm

UNITED ORTHOPEDIC CORP.

Femoral head bipolar component Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty Bipolar femoral head outer component, hemiarthroplasty

• Primary Device ID: 04712602344401
• NIH Device Record Key: 0c0ff054-ec0f-4feb-952e-a00406579bc6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U1 Hip System, Bipolar Cup Liner
• Version Model Number: 1601-1053
• Catalog Number: 1601-1053
• 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: 53 Millimeter
• Outer Diameter: 53 Millimeter
• Outer Diameter: 53 Millimeter
• Outer Diameter: 53 Millimeter
• Outer Diameter: 53 Millimeter
• Outer Diameter: 53 Millimeter
• Outer Diameter: 53 Millimeter
• Outer Diameter: 53 Millimeter
• Outer Diameter: 53 Millimeter
• Outer Diameter: 53 Millimeter
• Outer Diameter: 53 Millimeter
• Outer Diameter: 53 Millimeter
• Outer Diameter: 53 Millimeter
• Outer Diameter: 53 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04712602344401 [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