Catalog Number

CORA2020/B

Brand Name

CorVocet™

Version/Model Number

00884450477496

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

KNW

Product Code Name

INSTRUMENT, BIOPSY

Public Device Record Key

f5885d58-867a-41f8-9133-d8a4b92d3155

Public Version Date

October 11, 2021

Public Version Number

2

DI Record Publish Date

April 06, 2021

Package DI Number

20884450477490

Quantity per Package

4

Contains DI Package

10884450477493

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-