Catalog Number

MSC-1

Brand Name

DeRoyal

Version/Model Number

MSC-1

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

MDM

Product Code Name

INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Public Device Record Key

bbafb39c-fa2e-4f51-93c0-ee87683494dc

Public Version Date

March 22, 2022

Public Version Number

2

DI Record Publish Date

July 28, 2021

Package DI Number

50749756260997

Quantity per Package

20

Contains DI Package

00749756260992

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case