Catalog Number

5513247

Brand Name

LEADER

Version/Model Number

5513247

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

-

Product Code

LYL

Product Code Name

Accessories, solution, ultrasonic cleaners for lenses

Public Device Record Key

406b5004-9138-464f-bcdd-0c354116e645

Public Version Date

July 02, 2021

Public Version Number

3

DI Record Publish Date

August 29, 2019

Package DI Number

50096295137168

Quantity per Package

24

Contains DI Package

00096295137163

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE