Catalog Number

783409

Brand Name

Dealmed

Version/Model Number

783409

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

PUI

Product Code Name

Drape, Surgical, Exempt

Public Device Record Key

153b7aaf-5a16-41d1-b94a-3099b39c3f25

Public Version Date

September 06, 2022

Public Version Number

1

DI Record Publish Date

August 29, 2022

Package DI Number

10817415022254

Quantity per Package

50

Contains DI Package

00817415022257

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box