| Primary Device ID | 00862973000353 |
| NIH Device Record Key | da9a97ca-c663-4afd-809a-a145c56fd23c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EDLENi Dental Sensor - Size 2 |
| Version Model Number | S11685-16-43 |
| Company DUNS | 078801340 |
| Company Name | EDLEN IMAGING, LLC |
| 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 | false |
| 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 |
| Phone | 480-659-8430 |
| nick@edlenimaging.com |
| Width | 30.4 Millimeter |
| Width | 30.4 Millimeter |
| Storage Environment Temperature | Between -20 Degrees Celsius and 70 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00862973000353 [Primary] |
| MUH | System,X-Ray,Extraoral Source,Digital |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-10-09 |
| 00862973000346 - EDLENi Dental Sensor - Size 1 | 2018-03-29 EDLENi Dental Sensor, CMOS Image Sensor, CsI Scintillator, 2.5 meter cable |
| 00862973000353 - EDLENi Dental Sensor - Size 2 | 2018-03-29EDLENi Dental Sensor, CMOS image sensor, CsI Scintillator, 2.5 meter cable |
| 00862973000353 - EDLENi Dental Sensor - Size 2 | 2018-03-29 EDLENi Dental Sensor, CMOS image sensor, CsI Scintillator, 2.5 meter cable |