Catalog Number

-

Brand Name

Flexision

Version/Model Number

490103

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

4ba3a105-919c-47a5-82fc-7a2efa8b3a29

Public Version Date

March 02, 2020

Public Version Number

3

DI Record Publish Date

March 21, 2019

Package DI Number

10886874115968

Quantity per Package

5

Contains DI Package

00886874115961

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX