Catalog Number

4935

Brand Name

Kerlix

Version/Model Number

4935

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)

Yes

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

GDY

Product Code Name

GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Public Device Record Key

eb32bc29-d9f3-4338-b1b8-d64591fdbabe

Public Version Date

August 24, 2021

Public Version Number

3

DI Record Publish Date

June 27, 2018

Package DI Number

20884527016836

Quantity per Package

640

Contains DI Package

10884527016839

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE