Femoral component, CR, cemented 2103-1365

GUDID 04711605574495

Femoral component, CR, cemented, #6.5, left

UNITED ORTHOPEDIC CORP.

Cruciate-retaining total knee prosthesis

• Primary Device ID: 04711605574495
• NIH Device Record Key: 36f8ab5e-4fa4-4161-af28-adf25d25fe5f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Femoral component, CR, cemented
• Version Model Number: 2103-1365
• Catalog Number: 2103-1365
• 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	04711605574495 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150829

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

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: 2018-07-25
• Device Publish Date: 2015-12-04

On-Brand Devices [Femoral component, CR, cemented]

• 04711605574556: Femoral component, CR, cemented, #6.5, right
• 04711605574549: Femoral component, CR, cemented, #5.5, right
• 04711605574532: Femoral component, CR, cemented, #4.5, right
• 04711605574525: Femoral component, CR, cemented, #3.5, right
• 04711605574518: Femoral component, CR, cemented, #2.5, right
• 04711605574501: Femoral component, CR, cemented, #1.5, right
• 04711605574495: Femoral component, CR, cemented, #6.5, left
• 04711605574488: Femoral component, CR, cemented, #5.5, left
• 04711605574471: Femoral component, CR, cemented, #4.5, left
• 04711605574464: Femoral component, CR, cemented, #3.5, left
• 04711605574457: Femoral component, CR, cemented, #2.5, left
• 04711605574440: Femoral component, CR, cemented, #1.5, left