Catalog Number

60312

Brand Name

Halyard

Version/Model Number

92654

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K941464,K941464

Product Code

FDX

Product Code Name

endoscopic cytology brush

Public Device Record Key

edf48977-ffa3-4adc-92f9-fe2c371305cf

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

July 20, 2016

Package DI Number

30680651926549

Quantity per Package

10

Contains DI Package

10680651926545

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS