Catalog Number

189A005

Brand Name

Halyard

Version/Model Number

98589

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

BSP

Product Code Name

NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Public Device Record Key

56e66cdf-7e20-45d8-bc04-5a8c780284d1

Public Version Date

December 13, 2021

Public Version Number

5

DI Record Publish Date

December 21, 2016

Package DI Number

30680651985898

Quantity per Package

20

Contains DI Package

10680651985894

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

cs