Catalog Number

CMPTUPU50

Brand Name

WHITESTAR TECHNOLOGY

Version/Model Number

CMPTUPU50

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 19, 2019

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

HQC

Product Code Name

Unit, phacofragmentation

Public Device Record Key

0138d9f1-f616-49fb-aea3-c3d1c3051c90

Public Version Date

February 26, 2020

Public Version Number

5

DI Record Publish Date

January 22, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-