Primary Device ID | 00858475006153 |
NIH Device Record Key | eb3aa1f6-1599-4da2-9229-cb120b8008de |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | MOBILE-X |
Version Model Number | T100 |
Company DUNS | 024913248 |
Company Name | DENTERPRISE INTERNATIONAL, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Phone | 8003232690 |
info@denterpriseint.com |
Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00858475006153 [Primary] |
EHD | Unit, X-Ray, Extraoral With Timer |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2018-06-29 |
Device Publish Date | 2018-05-29 |
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. |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() MOBILE-X 90872857 not registered Live/Pending |
Tango Networks UK Ltd. 2021-08-09 |