Catalog Number

50109

Brand Name

Halyard

Version/Model Number

50109

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 16, 2018

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

K940431,K940431

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

59f7b9c8-cf7d-456f-9e87-746f27fab73c

Public Version Date

June 10, 2022

Public Version Number

7

DI Record Publish Date

June 05, 2017

Package DI Number

30680651501098

Quantity per Package

20

Contains DI Package

20680651501091

Package Discontinue Date

May 16, 2018

Package Status

Not in Commercial Distribution

Package Type

CS