Catalog Number

-

Brand Name

Duet®

Version/Model Number

46916

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

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

DEN120017

Product Code

GWM

Product Code Name

Device, monitoring, intracranial pressure

Public Device Record Key

1533f571-9f1b-41a0-81a9-0eb8cf5ab63d

Public Version Date

March 18, 2022

Public Version Number

1

DI Record Publish Date

March 10, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-