Catalog Number

30-40-3150

Brand Name

Medtfine

Version/Model Number

1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

9efb6a32-b9da-407a-9399-7d68b0e2647f

Public Version Date

October 23, 2019

Public Version Number

4

DI Record Publish Date

February 11, 2017

Package DI Number

M992304031505

Quantity per Package

12

Contains DI Package

M992304031503

Package Discontinue Date

-

Package Status

-

Package Type

corrugate carton