XPE Patellar, On set, 3 pegs 2403-3250

GUDID 04712771485301

XPE Patellar, On set, 3 pegs, X-Larger, ψ 38 mm

UNITED ORTHOPEDIC CORP.

Cruciate-retaining total knee prosthesis

• Primary Device ID: 04712771485301
• NIH Device Record Key: ef300d9e-eb77-47e6-9ed1-3fafeb37c095
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XPE Patellar, On set, 3 pegs
• Version Model Number: 2403-3250
• Catalog Number: 2403-3250
• 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	04712771485301 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103733

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 [XPE Patellar, On set, 3 pegs]

• 04712771485325: XPE Patellar, On set, 3 pegs, E-Larger, ψ 44 mm
• 04712771485318: XPE Patellar, On set, 3 pegs, XX-Larger, ψ 41 mm
• 04712771485301: XPE Patellar, On set, 3 pegs, X-Larger, ψ 38 mm
• 04712771485295: XPE Patellar, On set, 3 pegs, Larger, ψ 35 mm
• 04712771485288: XPE Patellar, On set, 3 pegs, Medium,ψ 32 mm
• 04712771485271: XPE Patellar, On set, 3 pegs, Small, ψ 29 mm
• 04712771485264: XPE Patellar, On set, 3 pegs, X-Small, ψ 26 mm