Catalog Number

48807

Brand Name

Halyard

Version/Model Number

48807

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

-

Product Code

PUI

Product Code Name

Drape, surgical, exempt

Public Device Record Key

ea6c5b1e-bda1-416b-8edd-4ac037748643

Public Version Date

March 31, 2022

Public Version Number

1

DI Record Publish Date

March 23, 2022

Package DI Number

30680651488078

Quantity per Package

90

Contains DI Package

20680651488071

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS