Catalog Number

PMA-GP-BAY

Brand Name

Halyard

Version/Model Number

98606

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

-

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

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Public Device Record Key

a8b6fa29-56ca-4901-93bb-7620eb537490

Public Version Date

June 05, 2020

Public Version Number

4

DI Record Publish Date

May 11, 2017

Package DI Number

30680651986062

Quantity per Package

25

Contains DI Package

20680651986065

Package Discontinue Date

October 05, 2017

Package Status

Not in Commercial Distribution

Package Type

CS