U2 U-Motion Acetabular Component 1203-2428-RA

GUDID 04719872167853

Ceramic femoral head trial, φ28mm, L

UNITED ORTHOPEDIC CORP.

Femoral head prosthesis trial

• Primary Device ID: 04719872167853
• NIH Device Record Key: e90b95bf-4648-4b3d-bb93-0533cc14b1fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U2 U-Motion Acetabular Component
• Version Model Number: 1203-2428-RA
• Catalog Number: 1203-2428-RA
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	04719872167853 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103497

FDA Product Code

• LPH: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[04719872167853]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-02-07
• Device Publish Date: 2018-06-25

On-Brand Devices [U2 U-Motion Acetabular Component]

• 04719872167860: Ceramic femoral head trial, φ32mm, L
• 04719872167853: Ceramic femoral head trial, φ28mm, L
• 04719872167839: Ceramic femoral head trial, φ32mm, M
• 04719872167822: Ceramic femoral head trial, φ28mm, M
• 04719872167808: Ceramic femoral head trial, φ32mm, S
• 04719872167792: Ceramic femoral head trial, φ28mm, S