Catalog Number

0570-0381

Brand Name

GlideScope®

Version/Model Number

BFlex™ 5.8

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

eea2161b-679a-4735-9a9d-7aaeb11e2821

Public Version Date

September 03, 2019

Public Version Number

1

DI Record Publish Date

August 26, 2019

Package DI Number

10879123006407

Quantity per Package

5

Contains DI Package

00879123006400

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-