Catalog Number

74471205

Brand Name

ACHIEVECAS

Version/Model Number

74471205

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 29, 2018

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

K033341

Product Code

HAW

Product Code Name

Neurological stereotaxic Instrument

Public Device Record Key

d4b69858-61ea-4241-a4e8-c708e37357b4

Public Version Date

October 30, 2018

Public Version Number

4

DI Record Publish Date

August 29, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-