Histofreezer 36F1C

GUDID 10850077006095

Histofreezer, Kit U.S, 36F1C The 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.

CRYOCONCEPTS, LP

General cryosurgical system, cryogen gas, mechanical
Primary Device ID10850077006095
NIH Device Record Key9ac43b3a-a348-45d9-9e9f-b4e291eb6ab8
Commercial Distribution StatusIn Commercial Distribution
Brand NameHistofreezer
Version Model Number1001-0294
Catalog Number36F1C
Company DUNS038024868
Company NameCRYOCONCEPTS, LP
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-855-355-2796
Emailsupport@cryoconcepts.com
Phone1-855-355-2796
Emailsupport@cryoconcepts.com
Phone1-855-355-2796
Emailsupport@cryoconcepts.com
Phone1-855-355-2796
Emailsupport@cryoconcepts.com
Phone1-855-355-2796
Emailsupport@cryoconcepts.com
Phone1-855-355-2796
Emailsupport@cryoconcepts.com
Phone1-855-355-2796
Emailsupport@cryoconcepts.com
Phone1-855-355-2796
Emailsupport@cryoconcepts.com
Phone1-855-355-2796
Emailsupport@cryoconcepts.com
Phone1-855-355-2796
Emailsupport@cryoconcepts.com
Phone1-855-355-2796
Emailsupport@cryoconcepts.com
Phone1-855-355-2796
Emailsupport@cryoconcepts.com
Phone1-855-355-2796
Emailsupport@cryoconcepts.com
Phone1-855-355-2796
Emailsupport@cryoconcepts.com
Phone1-855-355-2796
Emailsupport@cryoconcepts.com

Operating and Storage Conditions

Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight.
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight.
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight.
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight.
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight.
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight.
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight.
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight.
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight.
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight.
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight.
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight.
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight.
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Protect from sunlight.
Storage Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100850077006098 [Primary]
GS110850077006095 [Package]
Contains: 00850077006098
Package: Kit [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEHUnit, Cryosurgical, Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-02
Device Publish Date2020-06-24

On-Brand Devices [Histofreezer]

10850077006095Histofreezer, Kit U.S, 36F1C The Histofreezer Portable Cryosurgical System is used for the remov
00850077006128Histofreezer, Kit, U.S., 60MC2 + 10 The Histofreezer Portable Cryosurgical System is used for th
10850077006118Histofreezer, Kit, U.S., 5M1C The Histofreezer Portable Cryosurgical System is used for the remo
10850077006101Histofreezer, Kit, U.S., 36M1C The Histofreezer Portable Cryosurgical System is used for the rem
10850077006088Histofreezer, Kit, U.S., 40T1C The Histofreezer Portable Cryosurgical System is used for the rem

Trademark Results [Histofreezer]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HISTOFREEZER
HISTOFREEZER
73741009 1525479 Live/Registered
KONINKLIJKE UTERMOHLEN N.V.
1988-07-20

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