U2 Femoral component, CR, cemented 2103-1450

GUDID 04712602345583

U2 Femoral component, CR, cemented, #5, right

UNITED ORTHOPEDIC CORP.

Cruciate-retaining total knee prosthesis

• Primary Device ID: 04712602345583
• NIH Device Record Key: 1357538d-4e41-4463-bffc-a6913ff80a7d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U2 Femoral component, CR, cemented
• Version Model Number: 2103-1450
• Catalog Number: 2103-1450
• 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	04712602345583 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140073

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: 2018-07-13
• Device Publish Date: 2015-10-24

On-Brand Devices [U2 Femoral component, CR, cemented]

• 04712771506297: U2 Femoral component, CR, cemented, #7, right
• 04712771506280: U2 Femoral component, CR, cemented, #7, left
• 04712602345590: U2 Femoral component, CR, cemented, #6, right
• 04712602345583: U2 Femoral component, CR, cemented, #5, right
• 04712602345576: U2 Femoral component, CR, cemented, #4, right
• 04712602345569: U2 Femoral component, CR, cemented, #3, right
• 04712602345552: U2 Femoral component, CR, cemented, #2, right
• 04712602345545: U2 Femoral component, CR, cemented, #1, right
• 04712602345538: U2 Femoral component, CR, cemented, #6, left
• 04712602345521: U2 Femoral component, CR, cemented, #5, left
• 04712602345514: U2 Femoral component, CR, cemented, #4, left
• 04712602345507: U2 Femoral component, CR, cemented, #3, left
• 04712602345491: U2 Femoral component, CR, cemented, #2, left
• 04712602345484: U2 Femoral component, CR, cemented, #1, left