Catalog Number

-

Brand Name

QuadraSphere®

Version/Model Number

00884450275177

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

-

Product Code

KRD

Product Code Name

Device, Vascular, for Promoting Embolization

Public Device Record Key

5620e54e-d32d-4d80-b0e4-2f86abbc3991

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

August 22, 2016

Package DI Number

10884450275174

Quantity per Package

1

Contains DI Package

00884450275177

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-