Catalog Number

M10-327

Brand Name

DeRoyal

Version/Model Number

M10-327

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

CCX

Product Code Name

SUPPORT, PATIENT POSITION

Public Device Record Key

7c12575e-dc52-4e98-9452-84a5fbf4d784

Public Version Date

July 19, 2021

Public Version Number

1

DI Record Publish Date

July 09, 2021

Package DI Number

50749756730599

Quantity per Package

36

Contains DI Package

00749756730594

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case