Catalog Number

M2815D01

Brand Name

DeRoyal

Version/Model Number

M2815D01

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

KID

Product Code Name

RESTRAINT, WHEELCHAIR, NON-PROTECTIVE

Public Device Record Key

5742c4b2-876b-4f5e-90b5-4c536c2f1266

Public Version Date

August 11, 2021

Public Version Number

1

DI Record Publish Date

August 03, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-