Catalog Number

88441

Brand Name

Halyard

Version/Model Number

88441

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"

Yes

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

K083234,K083234

Product Code

KKX

Product Code Name

Drape, surgical

Public Device Record Key

fe34d9ed-6628-4164-a8f3-d1fb57fe2382

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

August 09, 2019

Package DI Number

30680651884412

Quantity per Package

4

Contains DI Package

10680651884418

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS