Catalog Number

01273L

Brand Name

LYFO DISK™

Version/Model Number

01273L

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 31, 2021

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

-

Product Code

JTR

Product Code Name

KIT, QUALITY CONTROL FOR CULTURE MEDIA

Public Device Record Key

12cf8c71-bf53-477f-8e0e-6681a6125f6b

Public Version Date

February 16, 2022

Public Version Number

2

DI Record Publish Date

April 30, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-