Catalog Number

31-703

Brand Name

DeRoyal

Version/Model Number

31-703

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

K973507,K973507

Product Code

FRO

Product Code Name

Dressing, wound, drug

Public Device Record Key

5cafa64a-8918-4de6-aa16-f93733c1dab5

Public Version Date

July 08, 2021

Public Version Number

1

DI Record Publish Date

June 30, 2021

Package DI Number

50749756028986

Quantity per Package

50

Contains DI Package

00749756028981

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case