Atomlab Wipe Test Counter 086-331

GUDID 00718175003343

Atomlab Wipe Test Counter

BIODEX MEDICAL SYSTEMS, INC.

Radioisotope calibration system
Primary Device ID00718175003343
NIH Device Record Key9f8491d0-f1fa-4d94-b713-d8f4cb546cfb
Commercial Distribution StatusIn Commercial Distribution
Brand NameAtomlab Wipe Test Counter
Version Model Number086-331
Catalog Number086-331
Company DUNS043833813
Company NameBIODEX MEDICAL SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100718175003343 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KPTCalibrator, Dose, Radionuclide

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-24
Device Publish Date2020-02-14

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