Catalog Number

REF 2004

Brand Name

088 Access System

Version/Model Number

FD 0456

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"

-

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

QJP

Product Code Name

Catheter, Percutaneous, Neurovasculature

Public Device Record Key

91e5c209-053b-4585-8be1-be3f35548c88

Public Version Date

December 22, 2021

Public Version Number

3

DI Record Publish Date

September 18, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-