Catalog Number

-

Brand Name

Smoke Evacuator Tubing

Version/Model Number

6084

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

K910377,K910377

Product Code

GCX

Product Code Name

Apparatus, Suction, Operating-Room, Wall Vacuum Powered

Public Device Record Key

fbaa8ad5-e879-45ed-8650-c2a88dba5e26

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

February 02, 2016

Package DI Number

20888937000058

Quantity per Package

10

Contains DI Package

00888937000054

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-