Orthonol
Orthonol(R) Preform Natural Arch MX.017 X.025 34MM
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | RMO, United States |
|---|---|
| FDA product code | ORT |
| Device type | Burst Suppression Detection Software For Electroencephalograph |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1400 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-08-18 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| A07075 | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Burst Suppression Detection Software For Electroencephalograph | GE Healthcare Finland OY | 3 |
| Carescape Canvas Smart Display | GE Healthcare Finland OY | 1 |
| CNS Envision | Natus Neurology Incorporated | 1 |
| Carescape B850 | GE Healthcare Finland OY | 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.