UltraPoint™
TE: Disposable Ultrapoint Monopolar Needle Electrodes: 28 GA., 37 MM Needle, 2.5 FT. (0.76 M) Single Orange Leadwire
2manufacturers in China registered for this device type
18catalogue numbers in this listing
1510(k) clearance
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 | Rochester Electro Medical, Inc., United States |
|---|---|
| FDA product code | IKT |
| Device type | Electrode, Needle, Diagnostic Electromyograph |
| Device class | Class 2 |
| Regulation | 21 CFR 890.1385 |
| Premarket notification | Exempt |
| Record published | 2016-12-07 |
| Record revised | 2019-05-21 (version 4) |
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 |
| Packaging | Pack of 25 |
| Distribution end date | 2019-05-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 016386 | Withdrawn | |
| 016383 | Withdrawn | |
| 016388 | Withdrawn | |
| 016393 | Withdrawn | |
| 016380 | Withdrawn | |
| 016391 | Withdrawn | |
| 016393 | Withdrawn | |
| 016383 | Withdrawn | |
| 016391 | Withdrawn | |
| 016386 | Withdrawn | |
| 016397 | Withdrawn | |
| 016395 | Withdrawn | |
| 016380 | Withdrawn | |
| 016388 | Withdrawn | |
| 016397 | Withdrawn | |
| 016384 | Withdrawn | |
| 016384 | Withdrawn | |
| 016395 | Withdrawn |
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 |
| Bio Protech | BIO Protech USA, Inc. | 19 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K080914 | 2008-07-15 |
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.