Catalog Number

-

Brand Name

Halyard

Version/Model Number

88461

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

K083234,K083234

Product Code

KKX

Product Code Name

Drape, surgical

Public Device Record Key

09c9bcf3-48a6-4bd7-974e-3b425cda80ad

Public Version Date

June 17, 2022

Public Version Number

7

DI Record Publish Date

April 15, 2016

Package DI Number

30680651884610

Quantity per Package

5

Contains DI Package

10680651884616

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS