Catalog Number

-

Brand Name

CVAC Aspiration System

Version/Model Number

CVAC70

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

K200419,K200419,K200419,K200419,K200419

Product Code

FED

Product Code Name

Endoscopic Access Overtube, Gastroenterology-Urology

Public Device Record Key

0528a3ea-1216-46f4-822f-9384e0cf2801

Public Version Date

December 09, 2020

Public Version Number

1

DI Record Publish Date

December 01, 2020

Package DI Number

20860005357707

Quantity per Package

2

Contains DI Package

00860005357703

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-