Catalog Number

PC-6X96

Brand Name

Covidien

Version/Model Number

PC-6X96

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)

Yes

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

d6e310cb-3020-43ba-b650-72cb9df83a4c

Public Version Date

August 24, 2022

Public Version Number

1

DI Record Publish Date

August 16, 2022

Package DI Number

30748426132196

Quantity per Package

20

Contains DI Package

00748426132195

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-