Bio Protech
DRH: Monopolar single use pencil,rocker switch; holster; spatula electrode; L 3 m(1 pc per pack, 20 packs in a inner box, 40 packs in a master case)
2manufacturers in China registered for this device type
19catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Pine Moon Electronics Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| BIO Protech Yantai Inc | Yantai | Shandong | Manufacturer | 12 |
Record
| Listed by | BIO Protech USA, Inc. |
|---|---|
| FDA product code | IKT |
| Device type | Electrode, Needle, Diagnostic Electromyograph |
| Device class | Class 2 |
| Regulation | 21 CFR 890.1385 |
| Record published | 2017-06-06 |
| Record revised | 2018-06-11 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Inner box of 25, master case of 8, master case of 2, master case of 20, inner box of 10, inner box of 20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NDR | In distribution | |
| DB-5 | In distribution | |
| DRH | In distribution | |
| BH7523P (Lifelines) | In distribution | |
| BM3726P (Lifelines) | In distribution | |
| BH2527P (Lifelines) | In distribution | |
| BM2526P (Lifelines) | In distribution | |
| BH3727P (Lifelines) | In distribution | |
| BE1227P-15 (Lifelines) | In distribution | |
| BC2526 (Lifelines) | In distribution | |
| NDB | In distribution | |
| BM7526 (Lifelines) | In distribution | |
| BM5026P (Lifelines) | In distribution | |
| DBH | In distribution | |
| BC3028 (Lifelines) | In distribution | |
| BE1227P-25 (Lifelines) | In distribution | |
| BE1227P-05 (Lifelines) | In distribution | |
| BM3728 (Lifelines) | In distribution | |
| BM2528 (Lifelines) | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Disposable EMG needle electrodes | Spes Medica Srl | 122 |
| Technomed Europe | Technomed Engineering B.V. | 92 |
| Cadwell | Technomed Engineering B.V. | 42 |
| Chalgren | Chalgren Enterprises, Inc. | 42 |
| Rhythmlink® | Rhythmlink International, LLC | 39 |
| Electrode, Needle, Diagnostic Electromyograph | Neurovision Medical Products, Inc. | 38 |
| MediMax Tech | Medimax Tech Inc. | 19 |
| UltraPoint™ | Rochester Electro Medical, Inc. | 18 |
| Bionen | Bionen SAS DI Barbara Nencioni & C. | 17 |
| Natus Neurology | Natus Neurology Incorporated | 13 |
| Neuroguard | Technomed Engineering B.V. | 11 |
| Teca Elite | Natus Manufacturing Limited | 11 |
Showing 12 of 39. All products under Electrode, Needle, Diagnostic Electromyograph
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.