Catalog Number

60631

Brand Name

Halyard

Version/Model Number

92763

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

K874004,K874004

Product Code

OCZ

Product Code Name

Endoscopic grasping/cutting instrument, non-powered

Public Device Record Key

7b4ee49d-c722-4452-99bb-535ab0249bfa

Public Version Date

November 16, 2018

Public Version Number

4

DI Record Publish Date

July 20, 2016

Package DI Number

30680651927638

Quantity per Package

5

Contains DI Package

10680651927634

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS