Cement restrictor, I type 1907-1018

GUDID 04711605569309

Cement restrictor, I type, 18C

UNITED ORTHOPEDIC CORP.

Metal-on-polyethylene total hip prosthesis

• Primary Device ID: 04711605569309
• NIH Device Record Key: e88244f1-19f1-48e6-b6e1-e982bfab8b7e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cement restrictor, I type
• Version Model Number: 1907-1018
• Catalog Number: 1907-1018
• 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

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04711605569309 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152530

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-09-10
• Device Publish Date: 2018-08-08

On-Brand Devices [Cement restrictor, I type]

• 04711605569309: Cement restrictor, I type, 18C
• 04711605569293: Cement restrictor, I type, 16C
• 04711605569286: Cement restrictor, I type, 14C
• 04711605569279: Cement restrictor, I type, 12C
• 04711605569262: Cement restrictor, I type, 10C
• 04711605569255: Cement restrictor, I type, 8C