Catalog Number

8888571406

Brand Name

Aqua-Seal

Version/Model Number

8888571406

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

efe062f7-277a-4cf2-aef3-0ea69d6672aa

Public Version Date

January 08, 2021

Public Version Number

6

DI Record Publish Date

September 24, 2016

Package DI Number

20884521061009

Quantity per Package

5

Contains DI Package

10884521061002

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE