Catalog Number

60812

Brand Name

Halyard

Version/Model Number

92771

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

-

Product Code

FBK

Product Code Name

endoscopic injection needle, gastroenterology-urology

Public Device Record Key

53d7f9bd-60d9-4f31-9917-0b043dc061ab

Public Version Date

November 16, 2018

Public Version Number

3

DI Record Publish Date

July 06, 2016

Package DI Number

30680651927713

Quantity per Package

10

Contains DI Package

10680651927719

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS