Catalog Number

100610HFIL-V

Brand Name

HydroFill Helical

Version/Model Number

100610HFIL-V

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

K112226

Product Code

HCG

Product Code Name

DEVICE, NEUROVASCULAR EMBOLIZATION

Public Device Record Key

5756f463-5ad0-4988-98e2-4de582f92125

Public Version Date

October 10, 2022

Public Version Number

5

DI Record Publish Date

August 07, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-