Catalog Number

MBR-000016

Brand Name

Navigation Patient Patches

Version/Model Number

MBR-000016

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

f2ee1f2a-f1b5-4c65-b07d-f45ff01f4cd4

Public Version Date

October 23, 2019

Public Version Number

2

DI Record Publish Date

June 08, 2018

Package DI Number

B634MBR0000161

Quantity per Package

3

Contains DI Package

B634MBR0000160

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box