Smil-O-Ray

GUDID 00858475006337

Hand-held intraoral dental x-ray system, digital

Primary Device ID	00858475006337
NIH Device Record Key	f9418e10-bd13-41f7-8115-80a2ebaf079f
Commercial Distribution Status	In Commercial Distribution
Brand Name	Smil-O-Ray
Version Model Number	1
Company DUNS	024913248
Company Name	DENTERPRISE INTERNATIONAL, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00858475006337 [Primary]

EHD	Unit, X-Ray, Extraoral With Timer

Steralize Prior To Use	false
Device Is Sterile	false

00858475006337 - Smil-O-Ray	2024-01-15Portable X-ray System
00858475006337 - Smil-O-Ray	2024-01-15 Portable X-ray System
00858475006269 - QuickRay DX Size 1	2023-08-02
00858475006276 - QuickRay DX Size 2	2023-08-02
00858475006115 - iCam	2022-02-11 Intraoral Camera
00858475006177 - InstaRay	2019-08-01
00858475006184 - InstaRay	2019-08-01 Indications for Use: Radiographic examination and diagnosis of diseases of the teeth, jaw and oral structure.
00858475006009 - Xray2Go	2018-07-06 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 #2	2018-07-06 Indications for Use: Radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structure.