Catalog Number

MBR-000020

Brand Name

Bronchoscope Sheath Valve

Version/Model Number

MBR-000020

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K173760,K173760

Product Code

EOQ

Product Code Name

Bronchoscope (Flexible Or Rigid)

Public Device Record Key

e90f3472-f75c-4d02-aaf0-c38afb0431be

Public Version Date

July 09, 2018

Public Version Number

1

DI Record Publish Date

June 08, 2018

Package DI Number

B634MBR0000201

Quantity per Package

20

Contains DI Package

B634MBR0000200

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box