Catalog Number

8001 0768

Brand Name

Heraeus Noblelight America LLC

Version/Model Number

Strahler HNI MAT 1000 F

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

K151674,K151674,K151674,K151674

Product Code

LEJ

Product Code Name

Booth, Sun Tan

Public Device Record Key

b1e5091b-62e7-4b1a-bc3b-d6c77cd48291

Public Version Date

March 11, 2020

Public Version Number

5

DI Record Publish Date

February 28, 2017

Package DI Number

54054657600572

Quantity per Package

100

Contains DI Package

14054657500577

Package Discontinue Date

January 27, 2020

Package Status

Not in Commercial Distribution

Package Type

CaseTertiary 100x