Catalog Number

783503

Brand Name

Dealmed

Version/Model Number

783503

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

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

eb5bc9d4-8f20-45ec-8cea-567e1860ca75

Public Version Date

August 24, 2021

Public Version Number

2

DI Record Publish Date

December 04, 2020

Package DI Number

00817415020680

Quantity per Package

15

Contains DI Package

00817415020512

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE