Gendex eXpert DC™ intraoral x-ray system EXPERTDC55 NA
GUDID EKAV082252120
55 Inch Reach
GENDEX CORP.
Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital Stationary intraoral dental x-ray system, digital| Primary Device ID | EKAV082252120 |
| NIH Device Record Key | 519fc68c-4eb2-426d-8668-0d51d28a53e0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gendex eXpert DC™ intraoral x-ray system |
| Version Model Number | 0.822.5212 |
| Catalog Number | EXPERTDC55 NA |
| Company DUNS | 144575763 |
| Company Name | GENDEX CORP. |
| 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 |
Customer Support Contacts
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com | |
| Phone | +18003238029 |
| info@gendex.com |
Operating and Storage Conditions
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EKAV082252120 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K992610
FDA Product Code
| EHD | UNIT, X-RAY, EXTRAORAL WITH TIMER |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-10-29 |
| Device Publish Date | 2016-09-27 |
On-Brand Devices [Gendex eXpert DC™ intraoral x-ray system]
| EKAV100625810 | 75 Inch Reach |
| EKAV082252140 | 65 Inch Reach |
| EKAV082252120 | 55 Inch Reach |
Trademark Results [Gendex eXpert DC]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GENDEX EXPERT DC 78853112 3399919 Dead/Cancelled |
DENTAL IMAGING TECHNOLOGIES CORPORATION 2006-04-04 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.