Catalog Number

5512827

Brand Name

LEADER

Version/Model Number

5512827

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

b5d72754-167e-4476-a018-17e97f45cbc2

Public Version Date

July 02, 2021

Public Version Number

2

DI Record Publish Date

June 28, 2019

Package DI Number

50096295137397

Quantity per Package

12

Contains DI Package

00096295137392

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE