Catalog Number

-

Brand Name

CAREFINE

Version/Model Number

1100027

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

1e5330c8-526d-4804-8d70-4710cf847d61

Public Version Date

July 03, 2019

Public Version Number

3

DI Record Publish Date

March 10, 2017

Package DI Number

20894743001783

Quantity per Package

24

Contains DI Package

00894743001789

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case