Catalog Number

-

Brand Name

X-CAL Calibrator

Version/Model Number

110-4008-0

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

-

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

K083200

Product Code

KRX

Product Code Name

CALIBRATOR FOR CELL INDICES

Public Device Record Key

3c6246ac-4b6b-41bc-a503-013536c79f7e

Public Version Date

September 18, 2018

Public Version Number

4

DI Record Publish Date

October 06, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-