Catalog Number

M10-039

Brand Name

DeRoyal

Version/Model Number

M10-039

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

-

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

-

Product Code

IMP

Product Code Name

CUSHION, WHEELCHAIR

Public Device Record Key

a7598b94-bd26-4889-904c-e67d91dda704

Public Version Date

August 11, 2021

Public Version Number

1

DI Record Publish Date

August 03, 2021

Package DI Number

50749756005772

Quantity per Package

35

Contains DI Package

00749756005777

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case