Catalog Number

502-001

Brand Name

TorqMax™

Version/Model Number

502-001AA

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

K093257,K093257

Product Code

DFC

Product Code Name

Lipoprotein, Low-Density, Antigen, Antiserum, Control

Public Device Record Key

7417c4fa-d9a8-4ad5-aa19-ae713d837408

Public Version Date

October 26, 2021

Public Version Number

4

DI Record Publish Date

February 06, 2015

Package DI Number

20813132020440

Quantity per Package

2

Contains DI Package

00813132020446

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box