Catalog Number

-

Brand Name

Exacta™

Version/Model Number

46713

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

K983799

Product Code

GWM

Product Code Name

DEVICE, MONITORING, INTRACRANIAL PRESSURE

Public Device Record Key

74068af7-48be-4f69-8c3e-c0bf3651ec55

Public Version Date

October 17, 2022

Public Version Number

3

DI Record Publish Date

July 07, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-