Megadyne
Smoke Evacuation Pencil, Telescopic, Stainless Electrode, , 22mm Connector, 9 Ft (2.74m) Tubing
3manufacturers in China registered for this device type
12catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Megadyne Medical Products, Inc., United States |
|---|---|
| FDA product code | FYD |
| Device type | Apparatus, Exhaust, Surgical |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5070 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K200250 |
| Record published | 2020-08-03 |
| Record revised | 2023-07-31 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment humidity 15 to 95 % RH; Storage environment temperature 5 to 50 °C |
| Packaging | Box of 10, pack of 20, case of 30, case of 960 |
| Distribution end date | 2021-12-31 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2406J | In distribution | |
| 2255J | In distribution | |
| 2555J | In distribution | |
| MESE1 | In distribution | |
| 2550J | In distribution | |
| 2403J | In distribution | |
| 3110-09EC | Withdrawn | |
| 2145 | Withdrawn | |
| 2140 | Withdrawn | |
| 3110-09 | Withdrawn | |
| 2150 | Withdrawn | |
| 3110-10 | Withdrawn |
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 |
| 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 |
| Steris | I.C. Medical, Inc. | 9 |
Showing 12 of 142. All products under Apparatus, Exhaust, Surgical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K200250 | 2020-06-26 |
| K191328 | 2019-07-26 |
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.