Catalog Number

-

Brand Name

Duet®

Version/Model Number

46912

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

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,DEN120017

Product Code

GWM

Product Code Name

Device, monitoring, intracranial pressure

Public Device Record Key

09dac9b0-6a57-4ef4-bc71-d661e85ba605

Public Version Date

February 22, 2021

Public Version Number

1

DI Record Publish Date

February 13, 2021

Package DI Number

20763000431277

Quantity per Package

10

Contains DI Package

00763000431273

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PK