Catalog Number

102250HFIL-V

Brand Name

HydroFill Helical

Version/Model Number

102250HFIL-V-A1

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

K113457

Product Code

KRD

Product Code Name

Device, Vascular, for Promoting Embolization

Public Device Record Key

b8ac2f5b-dbcd-4806-8bab-096b7479aad5

Public Version Date

October 10, 2022

Public Version Number

5

DI Record Publish Date

November 20, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-