Catalog Number

5130-30261

Brand Name

Capintec Dose Calibrator

Version/Model Number

CRC-77tHR

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

K162394

Product Code

KPT

Product Code Name

Calibrator, Dose, Radionuclide

Public Device Record Key

5a0fc8d6-49f7-4df4-89f1-4c0994b70daa

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 20, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-