Catalog Number

-

Brand Name

UltiCare

Version/Model Number

63004

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

K140949,K140949

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

8e79601b-2804-49ab-b046-0a9ad05b5437

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

20357515630043

Quantity per Package

100

Contains DI Package

10357515630046

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box