Catalog Number

SE-090

Brand Name

DC-UIBC-CAL

Version/Model Number

SE-090

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 02, 2017

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

-

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

K925877,K925877

Product Code

JIS

Product Code Name

CALIBRATOR, PRIMARY

Public Device Record Key

8a8542c6-8336-4d1d-a421-5b10bb54af82

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 20, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-