Catalog Number

-

Brand Name

Exacta™

Version/Model Number

27666

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

K983799

Product Code

GWM

Product Code Name

DEVICE, MONITORING, INTRACRANIAL PRESSURE

Public Device Record Key

aa4d1d22-ac90-440e-b121-abd4e46c263c

Public Version Date

October 17, 2022

Public Version Number

3

DI Record Publish Date

July 14, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-