Catalog Number

-

Brand Name

LOBO

Version/Model Number

LOBO-HP

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K192083,K192083,K192083

Product Code

KRD

Product Code Name

Device, Vascular, For Promoting Embolization

Public Device Record Key

42abc9de-ae38-4dcc-94cc-1a99a8b33c8d

Public Version Date

April 23, 2021

Public Version Number

3

DI Record Publish Date

January 07, 2020

Package DI Number

00850008222023

Quantity per Package

5

Contains DI Package

00850008222009

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton