Catalog Number

-

Brand Name

POP-6™ (960) Performance Optimized Polymer, 3500 Dx Series

Version/Model Number

4393711

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

BK110039

Product Code

PCA

Product Code Name

DNA genetic analyzer

Public Device Record Key

e55c59f0-762e-43a7-9b4b-e3704f75ee6d

Public Version Date

October 23, 2019

Public Version Number

6

DI Record Publish Date

August 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-