Catalog Number

11972219122

Brand Name

Elecsys PTH CalSet

Version/Model Number

11972219122

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 18, 2019

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

K070709

Product Code

JIT

Product Code Name

CALIBRATOR, SECONDARY

Public Device Record Key

6b4d61b3-472d-4366-8400-a90aa18664c6

Public Version Date

November 11, 2020

Public Version Number

5

DI Record Publish Date

September 20, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-