Brasseler USA
CP122NS6 GCP 122 NS #6 HDL 1P
4manufacturers in China registered for this device type
17catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (1), Shanghai (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Suzhou Virgil Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Hangzhou Tonglu Shikonghou Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 17 |
Record
| Listed by | Peter Brasseler Holdings, LLC |
|---|---|
| FDA product code | EMD |
| Device type | Hemostat, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Premarket notification | Exempt |
| Record published | 2022-12-08 |
| Record revised | 2023-08-10 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5023301U0 | In distribution | |
| 5001791U0 | In distribution | |
| 5023310U0 | In distribution | |
| 5023309U0 | In distribution | |
| 5023304U0 | In distribution | |
| 5001763U0 | In distribution | |
| 5023305U0 | In distribution | |
| 5001793U0 | In distribution | |
| 5001792U0 | In distribution | |
| 5023308U0 | In distribution | |
| 5023311U0 | In distribution | |
| 5023307U0 | In distribution | |
| 5023302U0 | In distribution | |
| 5023306U0 | In distribution | |
| 5023303U0 | In distribution | |
| 5023312U0 | In distribution | |
| 5001790U0 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 182 |
| Anmuth Medical International | Anmuth Medical International LLC | 163 |
| Power Dental USA | Power Dental U.S.A. Inc. | 78 |
| GEN2 | Surgix Medical LLC | 58 |
| Assi | Accurate Surgical & Scientific Instruments Corp. | 45 |
| J & J Instruments | J & J Instruments, LLC | 39 |
| Pomee | Pomee Corporation | 22 |
| Kohdent | Kohler Medizintechnik GmbH | 18 |
| Henry Schein | Henry Schein, Inc. | 14 |
| HU-Friedy | HU-Friedy MFG Co., LLC | 14 |
| Osung MND | Osung MND Co., Ltd. | 13 |
| Zoll-Dental | Zoll-Dental | 12 |
Showing 12 of 86. All products under Hemostat, Surgical
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.