Catalog Number

32-2174

Brand Name

DeRoyal

Version/Model Number

32-2174

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K070431,K070431

Product Code

FYA

Product Code Name

GOWN, SURGICAL

Public Device Record Key

16c7c830-bbeb-4340-a57c-27929cf27eea

Public Version Date

August 31, 2021

Public Version Number

1

DI Record Publish Date

August 23, 2021

Package DI Number

50749756354771

Quantity per Package

25

Contains DI Package

00749756354776

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case