U2 Tibial insert, PS 2303-3024

GUDID 04712602348089

U2 Tibial insert, PS, #2, 15mm

UNITED ORTHOPEDIC CORP.

Posterior-stabilized total knee prosthesis

• Primary Device ID: 04712602348089
• NIH Device Record Key: dd4e4ba2-3629-411a-846a-c555f2e515e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U2 Tibial insert, PS
• Version Model Number: 2303-3024
• Catalog Number: 2303-3024
• 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	04712602348089 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051640

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: 2018-07-18
• Device Publish Date: 2015-10-24

On-Brand Devices [U2 Tibial insert, PS]

• 04712602348294: U2 Tibial insert, PS, #6, 18mm
• 04712602348287: U2 Tibial insert, PS, #6, 15mm
• 04712602348270: U2 Tibial insert, PS, #6, 13mm
• 04712602348263: U2 Tibial insert, PS, #6, 11mm
• 04712602348256: U2 Tibial insert, PS, #6, 9mm
• 04712602348249: U2 Tibial insert, PS, #5, 18mm
• 04712602348232: U2 Tibial insert, PS, #5, 15mm
• 04712602348225: U2 Tibial insert, PS, #5, 13mm
• 04712602348218: U2 Tibial insert, PS, #5, 11mm
• 04712602348201: U2 Tibial insert, PS, #5, 9mm
• 04712602348195: U2 Tibial insert, PS, #4, 18mm
• 04712602348188: U2 Tibial insert, PS, #4, 15mm
• 04712602348171: U2 Tibial insert, PS, #4, 13mm
• 04712602348164: U2 Tibial insert, PS, #4, 11mm
• 04712602348157: U2 Tibial insert, PS, #4, 9mm
• 04712602348140: U2 Tibial insert, PS, #3, 18mm
• 04712602348133: U2 Tibial insert, PS, #3, 15mm
• 04712602348126: U2 Tibial insert, PS, #3, 13mm
• 04712602348119: U2 Tibial insert, PS, #3, 11mm
• 04712602348102: U2 Tibial insert, PS, #3, 9mm
• 04712602348096: U2 Tibial insert, PS, #2, 18mm
• 04712602348089: U2 Tibial insert, PS, #2, 15mm
• 04712602348072: U2 Tibial insert, PS, #2, 13mm
• 04712602348065: U2 Tibial insert, PS, #2, 11mm
• 04712602348058: U2 Tibial insert, PS, #2, 9mm
• 04712602348041: U2 Tibial insert, PS, #1, 18mm
• 04712602348034: U2 Tibial insert, PS, #1, 15mm
• 04712602348027: U2 Tibial insert, PS, #1, 13mm
• 04712602348010: U2 Tibial insert, PS, #1, 11mm
• 04712602348003: U2 Tibial insert, PS, #1, 9mm