Catalog Number

S011

Brand Name

Single Use Surgical Professional

Version/Model Number

S011

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)

-

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

f7ca613d-408c-45e3-ab02-b077465d770b

Public Version Date

April 20, 2020

Public Version Number

4

DI Record Publish Date

August 09, 2016

Package DI Number

05055299100134

Quantity per Package

25

Contains DI Package

05055299100905

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton