Catalog Number

8881225190

Brand Name

Monoject

Version/Model Number

8881225190

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

K912563,K912563

Product Code

FOZ

Product Code Name

Catheter,intravascular,therapeutic,short-term less than 30 days

Public Device Record Key

99fbea67-9d91-4bc2-8c0e-326e0fd76d6f

Public Version Date

April 07, 2021

Public Version Number

8

DI Record Publish Date

September 24, 2016

Package DI Number

20884521013015

Quantity per Package

50

Contains DI Package

10884521013018

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE