U2 Tibial insert, CR, plained 2303-1224

GUDID 04712602347785

U2 Tibial insert, CR, plained, #2, 15mm

UNITED ORTHOPEDIC CORP.

Posterior-stabilized total knee prosthesis

• Primary Device ID: 04712602347785
• NIH Device Record Key: cf411b22-e240-4365-b261-6b645005a59e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U2 Tibial insert, CR, plained
• Version Model Number: 2303-1224
• Catalog Number: 2303-1224
• 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	04712602347785 [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: 2018-07-16
• Device Publish Date: 2015-10-24

On-Brand Devices [U2 Tibial insert, CR, plained]

• 04712602347990: U2 Tibial insert, CR, plained, #6, 18mm
• 04712602347983: U2 Tibial insert, CR, plained, #6, 15mm
• 04712602347976: U2 Tibial insert, CR, plained, #6, 13mm
• 04712602347969: U2 Tibial insert, CR, plained, #6, 11mm
• 04712602347952: U2 Tibial insert, CR, plained, #6, 9mm
• 04712602347945: U2 Tibial insert, CR, plained, #5, 18mm
• 04712602347938: U2 Tibial insert, CR, plained, #5, 15mm
• 04712602347921: U2 Tibial insert, CR, plained, #5, 13mm
• 04712602347914: U2 Tibial insert, CR, plained, #5, 11mm
• 04712602347907: U2 Tibial insert, CR, plained, #5, 9mm
• 04712602347891: U2 Tibial insert, CR, plained, #4, 18mm
• 04712602347884: U2 Tibial insert, CR, plained, #4, 15mm
• 04712602347877: U2 Tibial insert, CR, plained, #4, 13mm
• 04712602347860: U2 Tibial insert, CR, plained, #4, 11mm
• 04712602347853: U2 Tibial insert, CR, plained, #4, 9mm
• 04712602347846: U2 Tibial insert, CR, plained, #3, 18mm
• 04712602347839: U2 Tibial insert, CR, plained, #3, 15mm
• 04712602347822: U2 Tibial insert, CR, plained, #3, 13mm
• 04712602347815: U2 Tibial insert, CR, plained, #3, 11mm
• 04712602347808: U2 Tibial insert, CR, plained, #3, 9mm
• 04712602347792: U2 Tibial insert, CR, plained, #2, 18mm
• 04712602347785: U2 Tibial insert, CR, plained, #2, 15mm
• 04712602347778: U2 Tibial insert, CR, plained, #2, 13mm
• 04712602347761: U2 Tibial insert, CR, plained, #2, 11mm
• 04712602347754: U2 Tibial insert, CR, plained, #2, 9mm
• 04712602347747: U2 Tibial insert, CR, plained, #1, 18mm
• 04712602347730: U2 Tibial insert, CR, plained, #1, 15mm
• 04712602347723: U2 Tibial insert, CR, plained, #1, 13mm
• 04712602347716: U2 Tibial insert, CR, plained, #1, 11mm
• 04712602347709: U2 Tibial insert, CR, plained, #1, 9mm