Catalog Number

-

Brand Name

Aegis Aerosol VacStation Primary Filter

Version/Model Number

005-00048

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

-

Product Code

EHZ

Product Code Name

Evacuator, Oral Cavity

Public Device Record Key

5d80b8e9-e6cc-4ab9-ac22-1aacd3cbc457

Public Version Date

May 07, 2020

Public Version Number

1

DI Record Publish Date

April 29, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-