Catalog Number

-

Brand Name

Duplospray

Version/Model Number

0600134

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

1df208fb-bf3e-4f78-8bd4-7ed3f557901e

Public Version Date

October 23, 2020

Public Version Number

1

DI Record Publish Date

October 15, 2020

Package DI Number

10815634020853

Quantity per Package

1

Contains DI Package

00815634020856

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-