Catalog Number

8215.716

Brand Name

NA

Version/Model Number

8215716

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 02, 2020

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KTI

Product Code Name

Bronchoscope accessory

Public Device Record Key

330e84aa-a895-46e7-a1f4-37e2c8638eba

Public Version Date

August 19, 2022

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-