Catalog Number

-

Brand Name

MT

Version/Model Number

CYB-30S-12C

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

K172663,K172663,K172663

Product Code

FDX

Product Code Name

Endoscopic Cytology Brush

Public Device Record Key

f43e247b-059a-436c-af53-8cd484d16f93

Public Version Date

January 10, 2022

Public Version Number

1

DI Record Publish Date

December 31, 2021

Package DI Number

16932503549032

Quantity per Package

20

Contains DI Package

06932503549035

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box