Catalog Number

-

Brand Name

Kernel

Version/Model Number

KN-4003B

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

K132643,K132643,K132643,K132643

Product Code

FTC

Product Code Name

Light, Ultraviolet, Dermatological

Public Device Record Key

09be4e64-4769-492b-aabc-cfaac7c53f45

Public Version Date

November 08, 2021

Public Version Number

7

DI Record Publish Date

July 12, 2016

Package DI Number

36928798600026

Quantity per Package

12

Contains DI Package

06928798600025

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-