Catalog Number

8000 4206

Brand Name

Original Hanau

Version/Model Number

Strahler OH C 620 LF

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 27, 2020

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

-

Product Code

LEJ

Product Code Name

Booth, Sun Tan

Public Device Record Key

5fe3ac8d-f822-44ce-b089-b872ce9b2742

Public Version Date

February 18, 2020

Public Version Number

3

DI Record Publish Date

February 28, 2017

Package DI Number

14054657500218

Quantity per Package

1

Contains DI Package

04054657500211

Package Discontinue Date

January 27, 2020

Package Status

Not in Commercial Distribution

Package Type

SecondaryPackaging