Catalog Number

-

Brand Name

Avenir

Version/Model Number

18CFR10034

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K173711

Product Code

HCG

Product Code Name

Device, Neurovascular Embolization

Public Device Record Key

504ff40f-fa4a-421a-9b38-15ad9fb70d6d

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

October 16, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-