Graft Board Round LED Backlight
Round LED back light used for Graft Boards in processing
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shandong (1), Jiangxi (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Deman Medical Equipment Group Co., Ltd. | Jining | Shandong | Manufacturer | 11 |
| Nanchang Micare Medical Equipment Co., Ltd. | Nanchang | Jiangxi | Manufacturer | 8 |
Record
| Listed by | Cole Instruments, United States |
|---|---|
| FDA product code | PEQ |
| Device type | Accessories To Examination Light |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6320 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-12-14 |
| Record revised | 2023-07-20 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Graft Board Round LED Backlight | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Valo | Ultradent Products Inc. | 1 |
| Variable Polarizing Hood | GlobalMed Holdings, LLC | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.