Catalog Number

11877771216

Brand Name

Triglycerides/Glycerol Blanked

Version/Model Number

11877771216

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K873049

Product Code

CDT

Product Code Name

LIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES

Public Device Record Key

12dadb76-b37d-4520-b6aa-64efed1db6cf

Public Version Date

August 13, 2021

Public Version Number

3

DI Record Publish Date

February 08, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-