Guard, Disk
OrthoSafe sports guard / Assortment - The safe and comfortable guard for all types of sports / For further information please visit our online-shop on www.dentaurum.de
2manufacturers in China registered for this device type
8catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Weihai Jieshi Commodity Manufacture Co., Ltd. | Weihai | Shandong | Manufacturer | 10 |
| Ascend Excellence Daily Products Jiangsu Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 4 |
Record
| Listed by | Dentaurum GmbH & Co. KG, Germany |
|---|---|
| FDA product code | EEJ |
| Device type | Guard, Disk |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6010 |
| Establishment | Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-15 |
| Record revised | 2021-09-07 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Special storage condition: No special storage conditions required |
| Distribution end date | 2022-01-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 074-001-00 | In distribution | |
| 074-000-00 | In distribution | |
| 074-201-00 | Withdrawn | |
| 074-100-00 | Withdrawn | |
| 074-206-00 | Withdrawn | |
| 074-200-00 | Withdrawn | |
| 074-101-00 | Withdrawn | |
| 074-203-00 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| The Orthodontic Store | Young Innovations Inc. | 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.