Catalog Number

8001 5355

Brand Name

Original Hanau

Version/Model Number

Strahler OH N 800 SF

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,K151674

Product Code

LEJ

Product Code Name

Booth, Sun Tan

Public Device Record Key

5417a105-22bf-489b-b320-ebfec58f3d0e

Public Version Date

March 18, 2020

Public Version Number

3

DI Record Publish Date

February 28, 2017

Package DI Number

54054657600640

Quantity per Package

100

Contains DI Package

14054657500645

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CaseTertiary 100x