Freezpen®
19 catalogue numbers from Freezpen 8g, listed by H&O Equipments, Nv/Sa, Belgium, under Unit, Cryosurgical, Accessories. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
19catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (1), Beijing (1), Tianjin (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Kesite Digital Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 4 |
| Hygea Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
| Medinux (Tianjin) Technologies Co., Ltd. | Tianjin | Tianjin | Manufacturer | 1 |
Record
| Listed by | H&O Equipments, Nv/Sa, Belgium |
|---|---|
| FDA product code | GEH |
| Device type | Unit, Cryosurgical, Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4350 |
| 510(k) | K024009 |
| Record published | 2023-03-12 |
| Record revised | 2022-11-28 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Packaging | Pack of 12, pack of 16 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| Freezpen 8g | In distribution | ||
| Freezpen 8G | In distribution | ||
| Freezpen 16G | In distribution | ||
| 16g cartridges for Freezpen | 12 | In distribution | |
| Freezpen 35G | In distribution | ||
| 35g cartridges for Freezpen | 6 | In distribution | |
| Freezpen | In distribution | ||
| Freezpen 35g | In distribution | ||
| Freezpen 8G | In distribution | ||
| 8g cartridges for Freezpen | 21 | In distribution | |
| 16g cartridges for Freezpen | 12 | In distribution | |
| 8g cartridges for Freezpen | 15 | In distribution | |
| 16g cartridges for Freezpen | 6 | In distribution | |
| 8g N2O cartridges for Freezpen | 15 | In distribution | |
| 8g cartridges for Freezpen | 21 | In distribution | |
| Freezpen 8g | In distribution | ||
| Freezpen 16G | In distribution | ||
| Freezpen 16g | In distribution | ||
| Freezpen 16g | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Frigitronics | Coopersurgical, Inc. | 42 |
| CryoProbe™ | H&O Equipments, Nv/Sa | 35 |
| Wallach | Coopersurgical, Inc. | 32 |
| Premier | Premier Dental Products Co. | 30 |
| Hygea | Hygea Medical Technology Co., Ltd. | 26 |
| truFreeze | CSA Medical | 20 |
| Leisegang Cryotip for LM-900 | Coopersurgical, Inc. | 15 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 13 |
| cryoICE Cryoablation System | Atricure, Inc. | 13 |
| CryoThin | Medinux (Tianjin) Technologies Co., Ltd. | 12 |
| Erbe | Erbe Elektromedizin GmbH | 12 |
| CVS Health | Woonsocket Prescription Center, Incorporated | 10 |
Showing 12 of 334. All products under Unit, Cryosurgical, Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K161615 | 2016-08-23 |
| K024009 | 2003-03-20 |
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.