Catalog Number

-

Brand Name

Axium Prime Detachable Coil System

Version/Model Number

FC-25-50-3D

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K162704

Product Code

HCG

Product Code Name

DEVICE, NEUROVASCULAR EMBOLIZATION

Public Device Record Key

73b05f3c-9b27-413f-b8af-2ba260d9a1b0

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

August 15, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-