Cryo Professional
Cryo Professional Mixed (30x5mm, 30x2mm) Applicators (6-Kit Case) Each individual kit (GTIN 08717484792780) contains: 2 Aerosol Cans (GTIN: 08717484792841) and 1 Applicator box (GTIN:…
Cryo Professional Mixed (30x5mm, 30x2mm) Applicators (6-Kit Case) Each individual kit (GTIN 08717484792780) contains: 2 Aerosol Cans (GTIN: 08717484792841) and 1 Applicator box (GTIN: 08717484792834)
3manufacturers in China registered for this device type
10catalogue numbers in this listing
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 | Koninklijke Utermöhlen N.V. |
|---|---|
| FDA product code | GEH |
| Device type | Unit, Cryosurgical, Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4350 |
| 510(k) | K152203 |
| Record published | 2024-06-26 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature up to 50 °C; Special storage condition: Protect from sunlight; Special storage condition: Store away from diathermy equipment, medical gases, and other types of incendiary sources. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| UTM0300 | In distribution | |
| UTM0300 | In distribution | |
| UTM0200 | In distribution | |
| UTM0400 | In distribution | |
| UTM0200 | In distribution | |
| UTM0400 | In distribution | |
| UTM0200 | In distribution | |
| UTM0300 | In distribution | |
| UTM0200 | In distribution | |
| UTM0400 | 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
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.