Catalog Number

-

Brand Name

PRESSANA

Version/Model Number

OPC-0308135

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 26, 2018

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

DQY

Product Code Name

Catheter, Percutaneous

Public Device Record Key

da3d9ab1-84dd-40f1-96ae-8b277aae628e

Public Version Date

June 10, 2022

Public Version Number

6

DI Record Publish Date

March 22, 2017

Package DI Number

14960685205028

Quantity per Package

1

Contains DI Package

04960685205021

Package Discontinue Date

-

Package Status

Not in Commercial Distribution

Package Type

-