Catalog Number

491253

Brand Name

BD SurePath™ Collection Vial Kit 500

Version/Model Number

491253

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 18, 2021

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,P970018

Product Code

MKQ

Product Code Name

Processor, Cervical Cytology Slide, Automated

Public Device Record Key

10a33477-9999-49df-90a7-873db856abb3

Public Version Date

October 18, 2021

Public Version Number

7

DI Record Publish Date

September 08, 2017

Package DI Number

30382904912537

Quantity per Package

20

Contains DI Package

10382904912533

Package Discontinue Date

October 18, 2021

Package Status

Not in Commercial Distribution

Package Type

Shelf Pack