Catalog Number

100152HFRM-V

Brand Name

HydroSoft 3D

Version/Model Number

100152HFRM-V-3D-A2

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"

Yes

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

KRD

Product Code Name

Device, Vascular, for Promoting Embolization

Public Device Record Key

c62f6f1d-e8c9-4792-9d95-a23266620aba

Public Version Date

March 28, 2022

Public Version Number

4

DI Record Publish Date

November 20, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-