Catalog Number

6242P

Brand Name

Curity

Version/Model Number

6242P

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

NAB

Product Code Name

Gauze / sponge,nonresorbable for external use

Public Device Record Key

ed00d034-4c71-4142-9e8f-d2750f7ae263

Public Version Date

August 24, 2021

Public Version Number

3

DI Record Publish Date

June 30, 2018

Package DI Number

30884527017199

Quantity per Package

600

Contains DI Package

10884527017195

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE