Mini Powered Cole Isolation Device
mini Powered Cole Isolation Device (mPCID). Sterilize handpiece before first use and before each use.
1manufacturer
1catalogue number
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Polyrack Science & Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 1 |
Record
| Listed by | Cole Instruments, United States |
|---|---|
| FDA product code | MOQ |
| Device type | Battery, Replacement, Rechargeable |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4820 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-02-04 |
| Record revised | 2024-07-26 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Storage | Storage environment atmospheric pressure 84.3 to 101.3 KiloPascal; Storage environment humidity 5 to 95 % RH; Storage environment temperature -20 to 60 °C |
| Distribution end date | 2024-07-25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| mPCID | Withdrawn |
Same Product Code
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| Battery, Replacement, Rechargeable | Synthes Gmbh | 17 |
| Zimmer Biomet™ | Zimmer Surgical, Inc. | 9 |
| MicroAire® | Microaire Surgical Instruments LLC | 4 |
| Acculan | Aesculap AG | 4 |
| Bioseal Inc. | Bioseal | 4 |
| Hall | ConMed Corporation | 4 |
| Acculan II | Aesculap AG | 3 |
| Unium | Synthes Gmbh | 3 |
| Powerpro | ConMed Corporation | 2 |
Showing 12 of 27. All products under Battery, Replacement, Rechargeable
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.