Catalog Number

M60-300

Brand Name

DeRoyal

Version/Model Number

M60-300

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

FMP

Product Code Name

Protector, skin pressure

Public Device Record Key

970e1342-8c3e-4e87-aa2b-58515c7154a3

Public Version Date

August 11, 2021

Public Version Number

1

DI Record Publish Date

August 03, 2021

Package DI Number

50749756660261

Quantity per Package

6

Contains DI Package

00749756660266

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case