Catalog Number

8003 0918

Brand Name

JK

Version/Model Number

Strahler JK 30/60 EF

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K151674,K151674,K151674

Product Code

LEJ

Product Code Name

Booth, Sun Tan

Public Device Record Key

10965bab-968b-410c-90e4-cebd89b1c88b

Public Version Date

March 18, 2020

Public Version Number

4

DI Record Publish Date

February 28, 2017

Package DI Number

14054657500058

Quantity per Package

1

Contains DI Package

04054657500051

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

SecondaryPackaging