Catalog Number

REF 4002

Brand Name

Full Length 088 x 132cm Access System

Version/Model Number

FD 1185

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

054e7283-2c38-49c6-ab98-d3a1f42a4e6b

Public Version Date

June 30, 2022

Public Version Number

1

DI Record Publish Date

June 22, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-