Catalog Number

-

Brand Name

Procedure Products Adapter

Version/Model Number

8033

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

K810921,K810921

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

df0bdfd9-c3f1-4de7-b716-a3ba5b2931a5

Public Version Date

August 09, 2018

Public Version Number

4

DI Record Publish Date

April 03, 2017

Package DI Number

B16080332

Quantity per Package

25

Contains DI Package

B16080331

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box