Catalog Number

D0009

Brand Name

Lifelong Matrix

Version/Model Number

D0009

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

K210103,K210103,K210103

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

490912bd-a450-4b90-9422-6b4dba773125

Public Version Date

January 31, 2022

Public Version Number

1

DI Record Publish Date

January 21, 2022

Package DI Number

18906067662078

Quantity per Package

100

Contains DI Package

08906067662071

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box