Catalog Number

-

Brand Name

Janach

Version/Model Number

J4491

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K130117

Product Code

HOZ

Product Code Name

Sponge, Ophthalmic

Public Device Record Key

9d2e6390-7c8f-4ccb-8aa2-dc56fd94f09f

Public Version Date

February 22, 2021

Public Version Number

2

DI Record Publish Date

August 27, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-