Verruca-Freeze
Verruca-Freeze 236ml Replacement Canister Triple Pack (708ml)
3manufacturers in China registered for this device type
10catalogue numbers in this listing
8510(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 | Cryosurgery, Inc., United States |
|---|---|
| FDA product code | GEH |
| Device type | Unit, Cryosurgical, Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4350 |
| Establishment | Manufacturer |
| 510(k) | K982506 |
| Record published | 2023-04-19 |
| Record revised | 2024-03-20 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| Storage | Storage environment temperature up to 120 °F; Special storage condition: Do not store near direct heat source |
| Sizes | Total volume 120 to 708 ml |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VFC50 | Total Volume 150 ml | In distribution |
| VFL200R | Total Volume 472 ml | In distribution |
| VFL100 | Total Volume 236 ml | In distribution |
| TKIT | Total Volume 120 ml | In distribution |
| VFL300R | Total Volume 708 ml | In distribution |
| INTRO | Total Volume 135 ml | In distribution |
| VFC65 | Total Volume 175 ml | In distribution |
| VFC130 | Total Volume 350 ml | In distribution |
| VFK50 | Total Volume 150 ml | In distribution |
| VFK65 | Total Volume 175 ml | 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 |
| Freezpen® | H&O Equipments, Nv/Sa | 19 |
| 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 |
Showing 12 of 334. All products under Unit, Cryosurgical, Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253000 | 2025-10-16 |
| K252903 | 2025-10-10 |
| K243487 | 2025-03-13 |
| K243454 | 2024-12-03 |
| K233347 | 2023-12-04 |
| K982506 | 1999-01-27 |
| K955083 | 1996-02-08 |
| K944221 | 1994-12-15 |
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.