Catalog Number

UCHRHK

Brand Name

Integra®

Version/Model Number

UCHRHK

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

-

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

K160811,K944463

Product Code

HAW

Product Code Name

Neurological stereotaxic Instrument

Public Device Record Key

a3679f18-485d-43a4-be7f-63b90b6b0b53

Public Version Date

October 26, 2022

Public Version Number

5

DI Record Publish Date

April 14, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-