Catalog Number

-

Brand Name

Shifeng

Version/Model Number

N-2115

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

a21461ed-ca79-44be-ad66-8e572ec58ec0

Public Version Date

April 26, 2021

Public Version Number

2

DI Record Publish Date

March 25, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-