Catalog Number

48086

Brand Name

Halyard

Version/Model Number

48086

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

2cef2b42-869f-40a7-8bdd-3f54f95e5481

Public Version Date

June 17, 2020

Public Version Number

1

DI Record Publish Date

June 09, 2020

Package DI Number

30680651480867

Quantity per Package

30

Contains DI Package

20680651480860

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS