Duns Number:038024868
Device Description: Histofreezer, Kit, U.S., 5M1CThe Histofreezer Portable Cryosurgical System is used for the Histofreezer, Kit, U.S., 5M1CThe 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
5M1C
Brand Name
Histofreezer
Version/Model Number
1001-0336
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
f1e5b6aa-1320-4f67-b10a-1ba7f755fc05
Public Version Date
April 07, 2021
Public Version Number
2
DI Record Publish Date
September 22, 2020
Package DI Number
10850077006118
Quantity per Package
5
Contains DI Package
00850077006111
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 |