Catalog Number

490189

Brand Name

BD FocalPoint™ GS Review Station

Version/Model Number

490189

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

P950009

Product Code

MNM

Product Code Name

Reader, Cervical Cytology Slide, Automated

Public Device Record Key

46aa5b73-5556-483e-ad3d-15e069e7d18a

Public Version Date

September 16, 2022

Public Version Number

5

DI Record Publish Date

September 08, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-