Catalog Number

-

Brand Name

Aqualine SID Suction Irrigation Device

Version/Model Number

S0004

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 27, 2019

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

b9048742-3bb1-424e-975c-66abe46a6b88

Public Version Date

August 25, 2020

Public Version Number

6

DI Record Publish Date

January 11, 2018

Package DI Number

20862106000308

Quantity per Package

6

Contains DI Package

10862106000301

Package Discontinue Date

December 27, 2019

Package Status

Not in Commercial Distribution

Package Type

-