Histofreezer FLEX

Primary DI
00850077006388
Brand
Histofreezer FLEX
Company
CRYOCONCEPTS, LP
Model
200-3050
Catalog number
50SB
Device 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.
Published
2020-09-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEHUnit, Cryosurgical, Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEHUnit, Cryosurgical, AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183601000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183601000CryoTouchCryoconcepts LP2019-04-18GEH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850077006388PackageGS15In Commercial Distribution
00850077006340PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850077006388008500770063888500770063880850077006388
00850077006340008500770063408500770063400850077006340

GMDN Terms#

Term, Definition table
TermDefinition
General cryosurgical system, cryogen gas, mechanicalAn assembly of devices designed to apply cold from a gaseous or liquid refrigerant (cryogen) [e.g., liquid nitrogen (LN2), nitrous oxide (N2O), carbon dioxide (CO2)] to a target tissue for its destruction and removal. The system typically includes a mechanical regulator to control the flow of cryogen, contained in an attached cylinder, and the probe(s) to apply the cold. The system is used across clinical specialties (e.g., general surgery, dermatology, oral surgery, gynaecology, urology, ENT, proctology, oncology) to remove malignant or abnormal benign tissues.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius50 Degrees Celsius
Special Storage Condition, Specify00Protect from sunlight
Storage Environment Temperature0 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-855-355-2796support@cryoconcepts.com

Regulatory Flags#

DUNS number
038024868
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850077006081Histofreezer1001-029340T1C2020-09-22
00850077006098Histofreezer1001-029436F1C2020-06-24
00850077006104Histofreezer1001-029536M1C2020-09-22
00850077006111Histofreezer1001-03365M1C2020-09-22
00850077006340Histofreezer FLEX200-305050SB2020-09-13
00850077006357Histofreezer FLEX200-405150SC2020-09-13
00850077006364Histofreezer FLEX200-505250SM2020-09-13
00850077006128Histofreezer1001-037560MC2 + 102020-09-22
00850077006371Histofreezer FLEX200-608080SM2020-09-13
10850077006088Histofreezer1001-029340T1C2020-09-22
10850077006101Histofreezer1001-029536M1C2020-09-22
10850077006118Histofreezer1001-03365M1C2020-09-22
00850077006395Histofreezer FLEX200-405150SC2020-09-13
00850077006401Histofreezer FLEX200-505250SM2020-09-13
10850077006095Histofreezer1001-029436F1C2020-06-24
00850077006210CryOmega160-2002160-20022020-01-27
00850077006067CryoLab Medical200-1000200-10002019-07-15
00850077006074CryoLab Aesthetics700-1000700-10002019-07-03
00850077006005CryOmega160-2001160-20012016-09-24
00850077006036CryOmega800-2001800-20012016-09-24

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