Catalog Number

-

Brand Name

BOEHRINGER® Smoke Removal System

Version/Model Number

5700

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"

Yes

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

FCZ

Product Code Name

Tube, Smoke Removal, Endoscopic

Public Device Record Key

567ba519-b853-4af0-bcaf-db80ed242800

Public Version Date

April 02, 2021

Public Version Number

2

DI Record Publish Date

February 01, 2020

Package DI Number

80816286020931

Quantity per Package

4

Contains DI Package

10816286020932

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box