Catalog Number

783640

Brand Name

Dealmed

Version/Model Number

859140003672

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

NAC

Product Code Name

Dressing, wound, hydrophilic

Public Device Record Key

53f12508-ab7e-4122-bfcb-deaaf23c6059

Public Version Date

August 19, 2022

Public Version Number

4

DI Record Publish Date

September 11, 2020

Package DI Number

10859140003672

Quantity per Package

6

Contains DI Package

00859140003675

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE