Catalog Number

8HP2S75

Brand Name

HydroPearl

Version/Model Number

8HP2S75

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K150870

Product Code

NAJ

Product Code Name

Agents, embolic, for treatment of uterine fibroids

Public Device Record Key

1d5ff9dd-3b3a-4c2c-b038-4eb8ac3f8571

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

August 07, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-