NOMAD MD™ handheld X-ray system FP 0202

GUDID EKAV085004710

Handheld x-ray

ARIBEX, INC.

Diagnostic x-ray system generator, hand-held
Primary Device IDEKAV085004710
NIH Device Record Keye6b23875-16e8-4c15-9e81-41115ab621c0
Commercial Distribution StatusIn Commercial Distribution
Brand NameNOMAD MD™ handheld X-ray system
Version Model Number0.850.0471
Catalog NumberFP 0202
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
HIBCCEKAV085004710 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IZLSystem, x-ray, mobile

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 MD™ handheld X-ray system]

EKAV101152780Handheld x-ray
EKAV085004710Handheld x-ray
EKAV085004700Handheld x-ray
EKAV085001120Handheld X-ray
EKAV085000300Handheld X-ray

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