Catalog Number

9006290

Brand Name

Premier Filter Pack for Premier Evacuator

Version/Model Number

9006290

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Product Code

FYD

Product Code Name

Apparatus, Exhaust, Surgical

Public Device Record Key

aabc0bde-ee49-4011-981d-2d280928a7d5

Public Version Date

August 10, 2018

Public Version Number

1

DI Record Publish Date

July 10, 2018

Package DI Number

D69190062901

Quantity per Package

5

Contains DI Package

D69190062900

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box of 5