Catalog Number

491324

Brand Name

BD SurePath™ Collection Vial Kit 25

Version/Model Number

491324

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 17, 2017

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

Product Code

MKQ

Product Code Name

Processor, Cervical Cytology Slide, Automated

Public Device Record Key

b5a75cd0-cbef-4655-9366-69d6138d1421

Public Version Date

April 05, 2019

Public Version Number

4

DI Record Publish Date

June 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-