Catalog Number

K20-5000

Brand Name

K-SPONGE SPEARS PACK OF 10

Version/Model Number

K20-5000

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

79c51b1f-3af6-4f0f-be1a-cae68167c114

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 22, 2016

Package DI Number

10841668112172

Quantity per Package

15

Contains DI Package

00841668112175

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box