Catalog Number

48098

Brand Name

Halyard

Version/Model Number

48098

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

-

Product Code

PUI

Product Code Name

Drape, surgical, exempt

Public Device Record Key

8ad10d89-1e6c-476d-9cd2-01c6f0ad2889

Public Version Date

June 17, 2020

Public Version Number

1

DI Record Publish Date

June 09, 2020

Package DI Number

30680651480980

Quantity per Package

10

Contains DI Package

20680651480983

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS