FDA.reportPublic FDA data

Atomlab Wipe Test Counter

Primary DI
00718175003343
Brand
Atomlab Wipe Test Counter
Company
BIODEX MEDICAL SYSTEMS, INC.
Model
086-331
Catalog number
086-331
Device description
Atomlab Wipe Test Counter
Published
2020-02-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K090296000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090296000ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336Biodex Medical Systems, Inc.2009-02-19KPT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00718175003343PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00718175003343007181750033437181750033430718175003343

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
043833813
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00718175003381SHARPS CONTAINER SHIELD 039-350039-3502019-05-31
00718175003657Neck Phantom 043-365043-3652018-02-15
00718175005002Xenon Rebreathing System 132-680132-6802019-09-30
00718175005019Xenon Rebreathing System 132-681132-6812019-10-16
00718175005040Xenon Rebreathing System 132-690132-6902019-10-16
00718175005057Xenon Rebreathing System 132-691132-6912019-10-16
00718175005064Xenon Rebreathing System 132-692132-6922019-10-16
00718175005071Xenon Rebreathing System 132-699132-6992019-10-16
00718175005088Xenon Rebreathing System 132-770132-7702019-10-16
00718175005101Xenon Rebreathing System 132-774132-7742019-10-17
00718175005125Xenon Rebreathing System 132-784132-7842019-10-16
00718175005132Xenon Rebreathing System 132-793132-7932019-10-16
00718175005149Xenon Rebreathing System 132-771132-7712019-10-16
00718175005156VENTI-SCAN IV177-075177-0752019-12-13
00718175005163AIR CUSHIONED FACE MASK132-685132-6852019-12-13
00718175005170AIR CUSHIONED FACE MASK132-695132-6952019-12-13
00718175005187AIR CUSHIONED FACE MASK132-698132-6982019-12-13
00718175005200BACTERIAL FILTER132-750132-7502019-12-13
00718175005248XENON CONVENIENCE KITS 134-772134-7722019-12-13
00718175002902LEAD LINED 244-157244-1572020-06-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08719324589017VIK203Comecer Netherlands B.V.KPT2018-02-06
08719324589024IBC-LiteComecer Netherlands B.V.KPT2018-02-06
08719324589048VDC606Comecer 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