Catalog Number

Not Applicable

Brand Name

MedSource Regulator

Version/Model Number

MS-28310

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"

-

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

CAN

Product Code Name

Regulator, Pressure, Gas Cylinder

Public Device Record Key

e288ffb7-9d45-4f4a-81a4-94d383a0a65e

Public Version Date

June 09, 2021

Public Version Number

1

DI Record Publish Date

June 01, 2021

Package DI Number

00840155400467

Quantity per Package

20

Contains DI Package

00840155400450

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case