VIK203 - Measuring unit for the dose calibrator - Comecer Netherlands B.V.

Duns Number:418153144

Device Description: Measuring unit for the dose calibrator

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More Product Details

Catalog Number

-

Brand Name

VIK203

Version/Model Number

0202020091

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

KPT

Product Code Name

Calibrator, dose, radionuclide

Device Record Status

Public Device Record Key

99f25515-945b-48c7-b96f-4465629d9d8a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 06, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"COMECER NETHERLANDS B.V." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 4