Catalog Number

8888571315

Brand Name

Aqua-Seal

Version/Model Number

8888571315

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

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

-

Product Code

GCX

Product Code Name

Apparatus, Suction, Operating-Room, Wall Vacuum Powered

Public Device Record Key

38490782-ac8a-4f74-bd54-82c811ad45a5

Public Version Date

January 08, 2021

Public Version Number

6

DI Record Publish Date

August 31, 2015

Package DI Number

10884521070189

Quantity per Package

5

Contains DI Package

20884521070186

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE