Catalog Number

-

Brand Name

N/A

Version/Model Number

EB11-J10

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

-

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

K210928,K210928

Product Code

EOQ

Product Code Name

BRONCHOSCOPE (FLEXIBLE OR RIGID)

Public Device Record Key

432107b6-f53b-4c98-86de-116599347850

Public Version Date

February 11, 2022

Public Version Number

1

DI Record Publish Date

February 03, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-