Catalog Number

-

Brand Name

UltiCare 5mm pen needle 5-pk

Version/Model Number

99553

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

3579f05f-7497-4174-af31-fd7ab1011b1b

Public Version Date

October 18, 2019

Public Version Number

1

DI Record Publish Date

October 10, 2019

Package DI Number

30357515895531

Quantity per Package

300

Contains DI Package

10357515710137

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-