Catalog Number

-

Brand Name

Kernel

Version/Model Number

KN-4006AL1S

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

K181805

Product Code

FTC

Product Code Name

Light, Ultraviolet, Dermatological

Public Device Record Key

1ec7e1dd-6642-4d5d-82cd-168dd5be9311

Public Version Date

March 18, 2019

Public Version Number

1

DI Record Publish Date

March 08, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-