Catalog Number

74451007

Brand Name

ACHIEVECAS

Version/Model Number

74451007

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

K043536

Product Code

HAW

Product Code Name

Neurological stereotaxic Instrument

Public Device Record Key

7a9f3750-3ba8-4772-bfd1-43f6459c8f08

Public Version Date

November 03, 2020

Public Version Number

5

DI Record Publish Date

September 28, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-