Catalog Number

M70-500IP

Brand Name

DeRoyal

Version/Model Number

M70-500IP

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

-

Product Code

KME

Product Code Name

BEDDING, DISPOSABLE, MEDICAL

Public Device Record Key

51aa33d1-8ebd-45dd-aa39-2e72ada24589

Public Version Date

February 21, 2022

Public Version Number

2

DI Record Publish Date

August 03, 2021

Package DI Number

50749756973507

Quantity per Package

20

Contains DI Package

00749756973502

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case