Catalog Number

-

Brand Name

Tianzi

Version/Model Number

27G×1/2

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K180259,K180259,K180259

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

87b3884a-02e2-439e-8479-efaebcfbe4be

Public Version Date

December 14, 2020

Public Version Number

1

DI Record Publish Date

December 05, 2020

Package DI Number

16935550811015

Quantity per Package

100

Contains DI Package

06935550811018

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box