Catalog Number

-

Brand Name

Shifeng

Version/Model Number

N-2315

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K142765

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

b485f219-62db-4b54-9b55-b2f27ab6262c

Public Version Date

April 26, 2021

Public Version Number

3

DI Record Publish Date

November 19, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-