Catalog Number

-

Brand Name

Tianzi

Version/Model Number

10ml

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"

Yes

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

-

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

3d583138-b5fa-4578-8a7c-5d3b6136c665

Public Version Date

December 14, 2020

Public Version Number

1

DI Record Publish Date

December 05, 2020

Package DI Number

16935550813019

Quantity per Package

25

Contains DI Package

06935550813012

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-