Catalog Number

-

Brand Name

Acu-Life (HE)

Version/Model Number

400812/400812A

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

e0946d1b-fff5-4419-9faa-334c29085995

Public Version Date

September 21, 2020

Public Version Number

1

DI Record Publish Date

September 11, 2020

Package DI Number

10079573108120

Quantity per Package

12

Contains DI Package

00079573108123

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

bag