NOMAD Pro 2™ FP 0190

GUDID EKAV085000250

Handheld X-ray

ARIBEX, INC.

Diagnostic x-ray system generator, hand-held
Primary Device IDEKAV085000250
NIH Device Record Key52bec22c-3dea-4197-8573-574c7bd0f528
Commercial Distribution StatusIn Commercial Distribution
Brand NameNOMAD Pro 2™
Version Model Number0.850.0025
Catalog NumberFP 0190
Company DUNS169065526
Company NameARIBEX, 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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+18663405522
Emailsupport@aribex.com

Operating and Storage Conditions

Handling Environment TemperatureBetween -5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEKAV085000250 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EHDUNIT, X-RAY, EXTRAORAL WITH TIMER

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [NOMAD Pro 2™]

EKAV085000280Handheld X-ray, Black
EKAV085000260Handheld X-ray
EKAV085000250Handheld X-ray
EKAV085000220Handheld X-ray, Black
EKAV085000210Handheld X-ray

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