Compound W®
Compound W® Nitrofreeze™ Nitrous Oxide Wart Removal System - yellow carton secondary sku
3manufacturers in China registered for this device type
7catalogue numbers in this listing
3510(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 | Medtech Products, Inc., United States |
|---|---|
| FDA product code | GEH |
| Device type | Unit, Cryosurgical, Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4350 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K140314 |
| Record published | 2020-01-16 |
| Record revised | 2025-06-26 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Protect from sunlight Do not expose to temps above 50C(100F) before first use or 35C(95F) after 1st use. Exposure to tem |
| Packaging | Shipping carton of 6, shipping case of 12, shipping carton of 12, inner pack di of 6, shipping case of 2, inner pack of 6 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NitroFreeze Yellow CWUS009101 | In distribution | |
| CW017201, CW012105 | In distribution | |
| CW044201, CW044104, CW044601 | In distribution | |
| CW017201, CW017105 | In distribution | |
| CW067601; CW067201; CW067202; CW068101 (First Aid) | In distribution | |
| CW066101; CW066601; CW066201; CW066501 | In distribution | |
| CWUS004502, CWUS004103, CWUS004602 | 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 |
|---|---|
| K242803 | 2024-11-06 |
| K172373 | 2017-11-02 |
| K161294 | 2016-09-15 |
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.