Catalog Number

19324

Brand Name

CCORE

Version/Model Number

19324

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K101598,K101598

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

5fc8fe28-5f48-496d-9eab-4cbad6b71e80

Public Version Date

December 22, 2021

Public Version Number

3

DI Record Publish Date

November 12, 2020

Package DI Number

00817602023401

Quantity per Package

15

Contains DI Package

00817602023203

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE