Catalog Number

-

Brand Name

Health Mart/UltiCare

Version/Model Number

2790467

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

0ed3f5e5-0a90-42f2-8571-ac20dd85a71d

Public Version Date

December 03, 2018

Public Version Number

1

DI Record Publish Date

November 01, 2018

Package DI Number

30357515904677

Quantity per Package

12

Contains DI Package

20357515904670

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-