Catalog Number

30-6100

Brand Name

PRIORITYONE

Version/Model Number

UG1602

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

K112382,K112382,K112382,K112382

Product Code

DXE

Product Code Name

Catheter, Embolectomy

Public Device Record Key

6e94e7ab-b528-4d20-a2c9-41818327dd38

Public Version Date

August 05, 2022

Public Version Number

5

DI Record Publish Date

September 16, 2016

Package DI Number

54543334177259

Quantity per Package

5

Contains DI Package

14543334177251

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton