FDA.report

COOL RENEWAL

Primary DI
00860441000416
Brand
COOL RENEWAL
Company
COOL RENEWAL, LLC
Model
CR-K1
Catalog number
CR-K1
Device description
COOL RENEWAL 170mL REUSABLE TREATMENT KIT WITH APPLICATORS & ACCESSORIES
Published
2017-03-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GEHUnit, Cryosurgical, Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
GEHUnit, Cryosurgical, AccessoriesGeneral, Plastic Surgery2

Premarket Submissions

SubmissionSupplement
K161296000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K161296000Cool RenewalCool Renewal, LLC2016-07-06GEH

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00860441000416PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00860441000416008604410004168604410004160860441000416

GMDN Terms

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.

Device Sizes

TypeValueUnit
Total Volume170Milliliter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00DO NOT STORE NEAR DIRECT HEAT SOURCE
Storage Environment Temperature0 Degrees Fahrenheit120 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
16158440132INFO@COOL-RENEWAL.COM

Regulatory Flags

DUNS number
079489305
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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 DIBrandModelCatalogPublished
00860441000409COOL RENEWALCR-KCR-K2017-03-31
00860441000423COOL RENEWALCR-RC1CR-RC12017-03-31
00860441000430COOL RENEWALCR-RCCR-RC2017-03-31

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