Elements
Elements Patient Lead Cord W/O Satellite
2manufacturers in China registered for this device type
5catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangxi (1), Hunan (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
| Denjoy Dental Co., Ltd. | Changsha | Hunan | Contract manufacturer | 17 |
Record
| Listed by | Ormco Corporation, United States |
|---|---|
| FDA product code | EAT |
| Device type | Tester, Pulp |
| Device class | Class 2 |
| Regulation | 21 CFR 872.1720 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-12 |
| Record revised | 2023-09-25 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Special storage condition: Relative Humidity 10% to 95% Atmospheric Pressure: 500-1400 hPa Store between -10 to +40 Celsius |
| Distribution end date | 2023-09-25 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 973-0320 | In distribution | ||
| 973-0301 | 3 | In distribution | |
| 973-0300 | In distribution | ||
| 973-0304 | Withdrawn | ||
| 973-0311 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Gentle Pulse™ | Parkell, Inc. | 11 |
| Touch ‘n Heat | Kerr Corporation | 9 |
| Digitest™ | Parkell, Inc. | 8 |
| Vitality Scanner | Kerr Corporation | 7 |
| Thermique™ | Parkell, Inc. | 6 |
| Buchanan Plugger | Ormco Corporation | 6 |
| Tester, Pulp | Parkell, Inc. | 6 |
| Heat Carrier | Ormco Corporation | 4 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 2 |
| Elements | Kerr Corporation | 2 |
| CanalPro | Coltene/Whaledent Gmbh & Co. KG | 2 |
| Patterson | Patterson Dental Supply, Inc. | 2 |
Showing 12 of 72. All products under Tester, Pulp
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.