Catalog Number

491330

Brand Name

BD Settling Chambers

Version/Model Number

491330

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 15, 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

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

cbe48c6e-4d1a-4841-be57-927b3e79ba4a

Public Version Date

April 05, 2019

Public Version Number

4

DI Record Publish Date

May 05, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-