Catalog Number

8000 8599

Brand Name

Original Hanau

Version/Model Number

Strahler OH N 70/120 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

Yes

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

1a1ccf92-af65-4dae-a2b1-0eb823c62dd6

Public Version Date

March 18, 2020

Public Version Number

3

DI Record Publish Date

December 13, 2016

Package DI Number

54054657600541

Quantity per Package

100

Contains DI Package

14054657500546

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CaseTertiary 100x