Catalog Number

-

Brand Name

TrueCare Biomedix

Version/Model Number

TCBTECR-25

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K210818,K210818,K210818

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

6f902f90-09ac-4258-9e2a-5ff50f022928

Public Version Date

October 21, 2021

Public Version Number

1

DI Record Publish Date

October 13, 2021

Package DI Number

40850789007657

Quantity per Package

400

Contains DI Package

30850789007650

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE