Identity
- Trade Name
- Histofreezer FLEX FDA UDI
- Generic Name
- General cryosurgical system, cryogen gas, mechanical FDA UDI
- Device Name
- Histofreezer FLEX Kit 50SB Small Bud Kit. The Histofreezer FLEX is intended for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures. The following are examples of the types of lesions that may be treated: Verruca (warts), Plantar warts, Seborrheic Keratoses, Actinic Keratoses, Achrochordon, Molluscum Contagiosum, Age Spots, Dermafibroma, Small Keloids, Granuloma Annulare, Porokeratosis Plantaris, Angiomas, Lentigo Maligna, Keratoacanthoma, Bowen’s Disease, Lentigo Discrete, Chondrodermatitis, Epithelial Nevus, Leukoplakia, Granuloma Pyogenicum and Pyogenic Granuloma. The Histofreezer FLEX should only be supplied to and used by licensed practitioners. FDA UDI
- Model / Reference
- 200-3050 FDA UDI
- Description
- Histofreezer FLEX Kit 50SB Small Bud Kit. The Histofreezer FLEX is intended for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures. The following are examples of the types of lesions that may be treated: Verruca (warts), Plantar warts, Seborrheic Keratoses, Actinic Keratoses, Achrochordon, Molluscum Contagiosum, Age Spots, Dermafibroma, Small Keloids, Granuloma Annulare, Porokeratosis Plantaris, Angiomas, Lentigo Maligna, Keratoacanthoma, Bowen’s Disease, Lentigo Discrete, Chondrodermatitis, Epithelial Nevus, Leukoplakia, Granuloma Pyogenicum and Pyogenic Granuloma. The Histofreezer FLEX should only be supplied to and used by licensed practitioners. FDA UDI
Identifiers
- Catalog Number
- 50SB FDA UDI
- Primary DI / UDI-DI
- 00850077006340 FDA UDI
- 510(k) Number
- K183601 FDA UDI
- FDA Product Code
- GEH FDA UDI
- GMDN Term
- General cryosurgical system, cryogen gas, mechanical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4350 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: General cryosurgical system, cryogen gas, mechanical
Histofreezer FLEX by Cryoconcepts, Lp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K183601 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Cryoconcepts, Lp
Sources (1)
- FDA UDI 9e34424f-2ca5-4bb0-a831-5fe7e1ec83e7 37 fields · synced Jun 1, 2026