Catalog Number

-

Brand Name

CAREFINE

Version/Model Number

1100035

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

05c2b7de-58ff-4859-9bc3-5e4ae47b081c

Public Version Date

July 03, 2019

Public Version Number

3

DI Record Publish Date

March 10, 2017

Package DI Number

20894743001813

Quantity per Package

24

Contains DI Package

00894743001819

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case