Premier
Evacuator Unit 110 Volt
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (1), Shandong (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Shuyou Surgical Instrument Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 13 |
| BIO Protech Yantai Inc | Yantai | Shandong | Manufacturer | 12 |
| Wickimed (Huizhou) Medical Equipment Manufacturing Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 3 |
Record
| Listed by | Premier Dental Products Co., United States |
|---|---|
| FDA product code | FYD |
| Device type | Apparatus, Exhaust, Surgical |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5070 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K945492 |
| Record published | 2016-09-16 |
| Record revised | 2022-01-28 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9006300 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Microtek | Microtek Medical LLC | 57 |
| Surgimedics® | Coastal Life Technologies, Inc. | 23 |
| Virosafe | ConMed Corporation | 22 |
| Buffalo Filter | Buffalo Filter Co., Inc. | 22 |
| ACU-Evac | Acuderm, Inc. | 21 |
| Neptune | Stryker GmbH | 14 |
| RapidVac | Covidien LP | 12 |
| Megadyne | Megadyne Medical Products, Inc. | 12 |
| Geiger Smoke Evacuator Filter | Dermatologic LAB AND Supply, Inc. | 12 |
| Apparatus, Exhaust, Surgical | Stryker GmbH | 11 |
| Apparatus, Exhaust, Surgical | ConMed Corporation | 10 |
| Conmed Buffalo Filter | ConMed Corporation | 10 |
Showing 12 of 142. All products under Apparatus, Exhaust, Surgical
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.