Catalog Number

-

Brand Name

eXcelon

Version/Model Number

M00564110

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

-

Product Code

EOQ

Product Code Name

BRONCHOSCOPE (FLEXIBLE OR RIGID)

Public Device Record Key

16c5ceff-33ae-4eb3-9896-542c8d3b8021

Public Version Date

July 12, 2019

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

08714729456469

Quantity per Package

5

Contains DI Package

08714729748236

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-