Catalog Number

K20-5011

Brand Name

K-SPONGE II SPEARS PACK OF 2

Version/Model Number

K20-5011

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

e6700a1d-a037-4de7-84a5-be4c8055d7de

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 12, 2016

Package DI Number

10841668112448

Quantity per Package

25

Contains DI Package

00841668112441

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box