U2 Femoral component, PS 2103-3270

GUDID 04712771505559

U2 Femoral component, PS, #7, right

UNITED ORTHOPEDIC CORP.

Cruciate-retaining total knee prosthesis

• Primary Device ID: 04712771505559
• NIH Device Record Key: 8162f9bc-305d-4982-850d-18b8e37b3078
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U2 Femoral component, PS
• Version Model Number: 2103-3270
• Catalog Number: 2103-3270
• 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	04712771505559 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120507

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, PS]

• 04712771505559: U2 Femoral component, PS, #7, right
• 04712771505542: U2 Femoral component, PS, #7, left
• 04712602345712: U2 Femoral component, PS, #6, right
• 04712602345705: U2 Femoral component, PS, #5, right
• 04712602345699: U2 Femoral component, PS, #4, right
• 04712602345682: U2 Femoral component, PS, #3, right
• 04712602345675: U2 Femoral component, PS, #2, right
• 04712602345668: U2 Femoral component, PS, #1, right
• 04712602345651: U2 Femoral component, PS, #6, left
• 04712602345644: U2 Femoral component, PS, #5, left
• 04712602345637: U2 Femoral component, PS, #5, left
• 04712602345620: U2 Femoral component, PS, #3, left
• 04712602345613: U2 Femoral component, PS, #2, left
• 04712602345606: U2 Femoral component, PS, #1, left