Catalog Number

-

Brand Name

Procedure Products, Inc.

Version/Model Number

8039

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 01, 2018

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

K810921

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

4decb7db-9ff0-4526-b911-d4c7bfd92bae

Public Version Date

December 03, 2018

Public Version Number

5

DI Record Publish Date

December 01, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-