FDA.reportPublic FDA data

VDC606

Primary DI
08719324589048
Brand
VDC606
Company
Comecer Netherlands B.V.
Model
0202020117
Device description
Dose Calibrator for the measuring of radiopharmaceutical activity in syringes and vials
Published
2018-02-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KPTCalibrator, dose, radionuclide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPTCalibrator, Dose, RadionuclideRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K030066000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030066000CAL/RAD MARK VI/VDC-505 DOSE CALIBRATOR, MODEL 34-165Nuclear Associates2003-08-29KPT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08719324589048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719324589048087193245890488719324589048

GMDN Terms#

Term, Definition table
TermDefinition
Radioisotope calibration systemA system of radioactivity measuring instruments designed for quantifying the amount of radiation in a radiopharmaceutical dose or other test samples inserted into a shielded chamber or well for measurement. The system's instruments radiation level measurements in units of Curie and/or Becquerel are used to quantify the radioactivity in diagnostic or therapeutic radiopharmaceuticals prior to and after patient administration. This will be used to measure radiation levels of in vitro diagnostic test samples, e.g., those required for Schilling tests, Cr-51 or I-125 blood volume.

Contacts#

Phone, Email table
PhoneEmail
+310513416964infonl@comecer.com

Regulatory Flags#

DUNS number
418153144
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08719324589024IBC-Lite02030100162018-02-06
08719324589000VIK20202020200012018-02-05
08719324589017VIK20302020200912018-02-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00718175003343Atomlab Wipe Test CounterBIODEX MEDICAL SYSTEMS, INC.KPT2020-02-14
08719324589017VIK203Comecer Netherlands B.V.KPT2018-02-06
08719324589024IBC-LiteComecer Netherlands B.V.KPT2018-02-06
08719324589000VIK202Comecer Netherlands B.V.KPT2018-02-05
00859942006065Capintec Dose CalibratorMirion Technologies (capintec), Inc.KPT2017-06-20
00718175003305Atomlab 500 Dose CalibratorBIODEX MEDICAL SYSTEMS, INC.KPT2016-11-02
00718175003329Atomlab 500 PlusBIODEX MEDICAL SYSTEMS, INC.KPT2016-11-02
00718175003350Atomlab Dose CalibratorBIODEX MEDICAL SYSTEMS, INC.KPT2016-11-02
00866562000212Standard Imaging HDR 1000 PlusSTANDARD IMAGING INC.KPT2016-10-11
00866562000250Standard Imaging IVB 1000 Well ChamberSTANDARD IMAGING INC.KPT2016-10-11
00859942006072Capintec Dose CalibratorMirion Technologies (capintec), Inc.KPT2016-09-27
00859942006089Capintec Dose CalibratorMirion Technologies (capintec), Inc.KPT2016-09-27
00859942006003Capintec Dose CalibratorMirion Technologies (capintec), Inc.KPT2016-09-14
00859942006010Capintec Dose CalibratorMirion Technologies (capintec), Inc.KPT2016-09-14
00859942006027Capintec Dose CalibratorMirion Technologies (capintec), Inc.KPT2016-09-14
00859942006034Capintec Dose CalibratorMirion Technologies (capintec), Inc.KPT2016-09-14
00859942006041Capintec Dose CalibratorMirion Technologies (capintec), Inc.KPT2016-09-14
00859942006058Capintec Dose CalibratorMirion Technologies (capintec), Inc.KPT2016-09-14
00813787020280I-Seed Agx100THERAGENICS CORPORATIONKPT2015-09-21
00813787020297I-Seed Agx100THERAGENICS CORPORATIONKPT2015-09-21
00813787020754TheraSeedTHERAGENICS CORPORATIONKPT2015-09-21
00813787020761TheraSeedTHERAGENICS CORPORATIONKPT2015-09-21