UCP Long stem, cemented, high offset 1107-3421

GUDID 04711605569217

UCP Long stem, cemented, high offset, #2, 180mm

UNITED ORTHOPEDIC CORP.

Metal-on-polyethylene total hip prosthesis

• Primary Device ID: 04711605569217
• NIH Device Record Key: 4be4a369-43dc-44ae-b59b-16a9c898df08
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UCP Long stem, cemented, high offset
• Version Model Number: 1107-3421
• Catalog Number: 1107-3421
• 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

• Length: 180 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04711605569217 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152530

FDA Product Code

• LZO: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-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: 2018-08-08
• Device Publish Date: 2016-03-31

On-Brand Devices [UCP Long stem, cemented, high offset]

• 04711605569248: UCP Long stem, cemented, high offset, #3, 230mm
• 04711605569231: UCP Long stem, cemented, high offset, #3, 210mm
• 04711605569224: UCP Long stem, cemented, high offset, #3, 180mm
• 04711605569217: UCP Long stem, cemented, high offset, #2, 180mm