Catalog Number

51300

Brand Name

Halyard

Version/Model Number

51300

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)

Yes

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

KKX

Product Code Name

Drape, surgical

Public Device Record Key

e4341b90-3887-4b26-809d-2171dbe6f486

Public Version Date

November 08, 2018

Public Version Number

4

DI Record Publish Date

September 21, 2016

Package DI Number

30680651513008

Quantity per Package

4

Contains DI Package

20680651513001

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS