Catalog Number

Art.- No. 591.71

Brand Name

Beurer

Version/Model Number

HT15

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

-

Product Code

LJL

Product Code Name

Detectors And Removers, Lice, (Including Combs)

Public Device Record Key

b9b24f14-d1bd-4a42-87be-2dcd427a8a25

Public Version Date

March 04, 2019

Public Version Number

1

DI Record Publish Date

January 31, 2019

Package DI Number

20853879007939

Quantity per Package

4

Contains DI Package

10853879007932

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case Pack