Uni-Ray HD

GUDID 00858475006030

Digital Dental Intra Oral Sensor is intended to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed and manipulated for diagnostic use by dentists.

DENTERPRISE INTERNATIONAL, INC.

Dental digital imaging sensor, intraoral
Primary Device ID00858475006030
NIH Device Record Key4d7e9745-9c7f-4f8b-8a2e-101406827397
Commercial Distribution StatusIn Commercial Distribution
Brand NameUni-Ray HD
Version Model NumberHDI-S 1.5
Company DUNS024913248
Company NameDENTERPRISE INTERNATIONAL, 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

Phone877-509-3180
Emailinfo@denterpriseintl.com
Phone877-509-3180
Emailinfo@denterpriseintl.com
Phone877-509-3180
Emailinfo@denterpriseintl.com
Phone877-509-3180
Emailinfo@denterpriseintl.com
Phone877-509-3180
Emailinfo@denterpriseintl.com
Phone877-509-3180
Emailinfo@denterpriseintl.com
Phone877-509-3180
Emailinfo@denterpriseintl.com
Phone877-509-3180
Emailinfo@denterpriseintl.com
Phone877-509-3180
Emailinfo@denterpriseintl.com
Phone877-509-3180
Emailinfo@denterpriseintl.com
Phone877-509-3180
Emailinfo@denterpriseintl.com
Phone877-509-3180
Emailinfo@denterpriseintl.com
Phone877-509-3180
Emailinfo@denterpriseintl.com
Phone877-509-3180
Emailinfo@denterpriseintl.com
Phone877-509-3180
Emailinfo@denterpriseintl.com
Phone877-509-3180
Emailinfo@denterpriseintl.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100858475006030 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MUHSystem,X-Ray,Extraoral Source,Digital

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 Date2017-02-17

Devices Manufactured by DENTERPRISE INTERNATIONAL, INC.

00858475006337 - Smil-O-Ray2024-01-15 Portable X-ray System
00858475006269 - QuickRay DX Size 12023-08-02
00858475006276 - QuickRay DX Size 22023-08-02
00858475006115 - iCam2022-02-11 Intraoral Camera
00858475006177 - InstaRay2019-08-01
00858475006184 - InstaRay2019-08-01 Indications for Use: Radiographic examination and diagnosis of diseases of the teeth, jaw and oral structure.
00858475006009 - Xray2Go2018-07-06 Indications for Use: The Portable X-ray system (Model: EXARO, Xray2GO) is intended to be used by trained dentists and dental tec
00858475006016 - QuickRay HD #22018-07-06 Indications for Use: Radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structure.

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