Catalog Number

-

Brand Name

PIPELINE

Version/Model Number

FA-77500-10

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 28, 2018

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

P100018

Product Code

OUT

Product Code Name

Intracranial aneurysm flow diverter

Public Device Record Key

a07eb07d-0dd3-430a-8e01-fdc1c6aeefc4

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

April 03, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-