Catalog Number

-

Brand Name

Single Use Guiding Device

Version/Model Number

CC-220DR

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"

Yes

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

K192164,K192164

Product Code

BTG

Product Code Name

Brush, biopsy, bronchoscope (non-rigid)

Public Device Record Key

ccb7ec2b-83a1-46e9-a564-7febddef2935

Public Version Date

October 11, 2021

Public Version Number

2

DI Record Publish Date

September 07, 2021

Package DI Number

14953170406178

Quantity per Package

1

Contains DI Package

04953170406171

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-