Catalog Number

-

Brand Name

UltiCare

Version/Model Number

0435PL

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"

Yes

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

-

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

d4e58482-061f-4990-9e06-4bb6eebd4eda

Public Version Date

April 06, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

20357515910077

Quantity per Package

10

Contains DI Package

10357515950113

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box