Catalog Number

-

Brand Name

Hourglass Peripheral Embolization Device

Version/Model Number

PEP-002-US

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"

-

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

K200083

Product Code

KRD

Product Code Name

Device, Vascular, For Promoting Embolization

Public Device Record Key

d8ba09a5-e45c-4710-a0d1-07a4f63bbe80

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

May 29, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-