Catalog Number

-

Brand Name

UltiCare

Version/Model Number

03259

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

K103011,K103011

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

52ade093-19e4-4c2e-acc5-638d76d3fb2d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

20357515032595

Quantity per Package

100

Contains DI Package

10357515032598

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box