Catalog Number

-

Brand Name

Procedure Products waste bag

Version/Model Number

4822-10

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K874037,K874037

Product Code

DQO

Product Code Name

Catheter, Intravascular, Diagnostic

Public Device Record Key

3949275e-deb0-41e0-bff6-b4d3dbdfed0f

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

April 03, 2017

Package DI Number

B1604822102

Quantity per Package

10

Contains DI Package

B1604822101

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box