U2 Acetabular Components 1403-6258

GUDID 04719872168423

U2 Acetabular cup liner trial, ID26mm, 10°×58mm

UNITED ORTHOPEDIC CORP.

Femoral stem prosthesis trial

• Primary Device ID: 04719872168423
• NIH Device Record Key: d735f007-bd71-4c24-a469-b84ea8298c6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: U2 Acetabular Components
• Version Model Number: 1403-6258
• Catalog Number: 1403-6258
• 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: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com
• Phone: +886229294567
• Email: tw.service@unitedorthopedic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719872168423 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050262

FDA Product Code

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

Sterilization

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

[04719872168423]

Moist Heat or Steam Sterilization

[04719872168423]

Moist Heat or Steam Sterilization

[04719872168423]

Moist Heat or Steam Sterilization

[04719872168423]

Moist Heat or Steam Sterilization

[04719872168423]

Moist Heat or Steam Sterilization

[04719872168423]

Moist Heat or Steam Sterilization

[04719872168423]

Moist Heat or Steam Sterilization

[04719872168423]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-12
• Device Publish Date: 2022-07-04

On-Brand Devices [U2 Acetabular Components]

• 04719872177869: U2 Acetabular case
• 04719872177852: Acetabular MIS case
• 04719872173571: U2 Acetabular case
• 04719872173564: Screw set case
• 04719872173557: Acetabular MIS case
• 04719872173540: MIS set case
• 04719872173533: Cup reamer set case
• 04719872140153: Flexible drill, 75mm
• 04719872140146: Acetabular MIS case
• 04719872161271: XPE cup liner trial, ID 32mm, 10°x58mm
• 04719872161158: XPE cup liner trial, ID 28mm, 10°x58mm
• 04719872161561: Acetabular cup liner trial, ID 26mm, 10°×46mm
• 04719872161554: Acetabular cup liner trial, ID26mm, 10°×44mm
• 04719872168447: U2 Acetabular cup liner trial, ID26mm, 10°×62mm
• 04719872168430: U2 Acetabular cup liner trial, ID26mm, 10°×60mm
• 04719872168423: U2 Acetabular cup liner trial, ID26mm, 10°×58mm
• 04719872168416: U2 Acetabular cup liner trial, ID26mm, 10°×56mm
• 04719872168409: U2 Acetabular cup liner trial, ID26mm, 10°×54mm
• 04719872168393: U2 Acetabular cup liner trial, ID26mm, 10°×52mm
• 04719872168386: U2 Acetabular cup liner trial, ID26mm, 10°×50mm
• 04719872168379: U2 Acetabular cup liner trial, ID26mm, 10°×48mm
• 04719872168164: Cup trial, φ70mm
• 04719872168140: Cup trial, φ68mm
• 04719872168126: Cup trial, φ66mm
• 04719872168102: Cup trial, φ64mm
• 04719872168089: Cup trial, φ62mm
• 04719872168065: Cup trial, φ60mm
• 04719872168041: Cup trial, φ58mm
• 04719872168027: Cup trial, φ56mm
• 04719872168003: Cup trial, φ54mm
• 04719872167983: Cup trial, φ52mm
• 04719872167969: Cup trial, φ50mm
• 04719872167945: Cup trial, φ48mm
• 04719872167921: Cup trial, φ46mm
• 04719872167907: Cup trial, φ44mm
• 04719872167884: Cup trial, φ42mm