Catalog Number

-

Brand Name

TrueCare Biomedix

Version/Model Number

TCBSYR60L-30

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 19, 2020

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K083686,K083686

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

40732b78-6c6c-4f68-aac5-8ca3cac8c7c8

Public Version Date

May 03, 2021

Public Version Number

6

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-