Duns Number:038024868
Device Description: Histofreezer FLEX Kit 50SC Small Cone Kit. The Histofreezer FLEX is intended for the surg Histofreezer FLEX Kit 50SC Small Cone 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.
Catalog Number
50SC
Brand Name
Histofreezer FLEX
Version/Model Number
200-4051
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K183601,K183601
Product Code
GEH
Product Code Name
Unit, Cryosurgical, Accessories
Public Device Record Key
d046e891-77bb-407f-983d-888b09fdf7c0
Public Version Date
April 07, 2021
Public Version Number
2
DI Record Publish Date
September 13, 2020
Package DI Number
00850077006395
Quantity per Package
5
Contains DI Package
00850077006357
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Kit
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 12 |