Catalog Number

490522

Brand Name

BD SurePath

Version/Model Number

490522

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 23, 2015

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

Yes

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

P970018,P970018

Product Code

MKQ

Product Code Name

Processor, Cervical Cytology Slide, Automated

Public Device Record Key

a56cb9bc-b673-4a72-8c45-51d2174e83a5

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 23, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-