Duns Number:038024868
Device Description: Histofreezer, Kit, U.S., 60MC2 + 10The Histofreezer Portable Cryosurgical System is used f Histofreezer, Kit, U.S., 60MC2 + 10The Histofreezer Portable Cryosurgical System is used for the removal of warts and other benign skin lesions: Genital Lesions, Molluscum Contagiosum, Seborrheic Keratoses, Skin Tags, Verruca Plantaris, Verruca Vulgaris, Verruca Plana, Actinic Keratoses (Facial and Non-Facial), and Lentigo (Facial and Non-Facial). The Histofreezer System should only be supplied to and used by medically trained healthcare professionals.
Catalog Number
60MC2 + 10
Brand Name
Histofreezer
Version/Model Number
1001-0375
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
K990877,K990877
Product Code
GEH
Product Code Name
Unit, Cryosurgical, Accessories
Public Device Record Key
49b9ab7e-a312-445e-ac7c-36c4f7ca0ed0
Public Version Date
April 07, 2021
Public Version Number
2
DI Record Publish Date
September 22, 2020
Package DI Number
10850077006125
Quantity per Package
5
Contains DI Package
00850077006128
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 |