Catalog Number

M70-500TS

Brand Name

DeRoyal

Version/Model Number

M70-500TS

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

FMR

Product Code Name

DEVICE, TRANSFER, PATIENT, MANUAL

Public Device Record Key

0b1cf719-22ba-4210-aad4-34f0df9a5c8b

Public Version Date

August 11, 2021

Public Version Number

1

DI Record Publish Date

August 03, 2021

Package DI Number

50749756973521

Quantity per Package

10

Contains DI Package

00749756973526

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case