Catalog Number

-

Brand Name

National Biological Corporation

Version/Model Number

UHU-328

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K041212

Product Code

FTC

Product Code Name

Light, Ultraviolet, Dermatological

Public Device Record Key

adabc70e-176e-4d80-9de2-e6ae513ad5e3

Public Version Date

December 21, 2018

Public Version Number

4

DI Record Publish Date

March 08, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-