Catalog Number

74452317

Brand Name

ACHIEVECAS

Version/Model Number

74452317

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 17, 2022

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

5d252a8c-4b53-437e-8138-6dbca0717b6f

Public Version Date

March 18, 2022

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

-