Catalog Number

K20-5021

Brand Name

K-SPONGE-II CHAYET LASIK DRAIN

Version/Model Number

K20-5021

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

HOZ

Product Code Name

Sponge, Ophthalmic

Public Device Record Key

820ae03b-bb8b-4102-bb1a-393a154d0f8f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 22, 2016

Package DI Number

10841668112202

Quantity per Package

20

Contains DI Package

00841668112205

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box