Catalog Number

141906

Brand Name

Argyle

Version/Model Number

141906

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

Yes

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

15097696-4721-448a-8903-451a040b45b9

Public Version Date

February 15, 2019

Public Version Number

5

DI Record Publish Date

October 20, 2016

Package DI Number

20884527002594

Quantity per Package

100

Contains DI Package

10884527002597

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case