Catalog Number

-

Brand Name

UltiCare

Version/Model Number

09543

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

K100812,K100812,K100812

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

4752d325-250b-4c2f-97be-9a58754f26c0

Public Version Date

February 24, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

20357515125433

Quantity per Package

1

Contains DI Package

20357515095439

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

UltiGuard