Catalog Number

-

Brand Name

EasyCal

Version/Model Number

9062

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

K191589,K191592

Product Code

NXO

Product Code Name

Calprotectin, Fecal

Public Device Record Key

bc1198bf-2b16-4f6e-92ff-795840a64072

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

November 05, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-