FDA.reportPublic FDA data

Dermal Cooling System

Primary DI
00850019947564
Brand
Dermal Cooling System
Company
R2 Technologies, Inc.
Model
M1-TIP1-10
Catalog number
M1-TIP1-10
Device description
Dermal Cooling System smooth tip
Published
2023-06-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILOPack, hot or cold, water circulating
QPZContact cooling for skin lesion pain relief

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILOPack, Hot Or Cold, Water CirculatingPhysical Medicine2
QPZContact Cooling For Skin Lesion Pain ReliefGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213294000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213294000Dermal Cooling SystemR2 Technologies, Inc.2022-11-10QPZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850019947564PrimaryGS10
00850019947991Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850019947564008500199475648500199475640850019947564
00850019947991008500199479918500199479910850019947991

GMDN Terms#

Term, Definition table
TermDefinition
General cryosurgical system, thermo-electric coolerAn assembly of electrically-powered devices designed to ablate benign lesions of the skin through cooling (cryosurgery) and may in addition be intended for temporary reduction of pain, swelling, inflammation, and/or hematoma associated with minor surgical procedures. It includes a control unit, thermoelectric cooling unit and a noninvasive handpiece typically mounted on a mobile stand/trolley; it is not intended to use liquid refrigerant (cryogen).

Contacts#

Phone, Email table
PhoneEmail
+1(925)378-4400info@r2technologies.com

Regulatory Flags#

DUNS number
080023734
Device count
10
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850019947847Dermal Cooling SystemM1-TIP3-10M1-TIP3-102023-06-09
00850019947861Dermal Cooling SystemM1-TIP1-20M1-TIP1-202023-06-09
00850019947878Dermal Cooling SystemM1-TIP3-20M1-TIP3-202023-06-09
00850019947045Dermal Cooling SystemHP-002M1-HP-025-002022-02-01
00850019947533Dermal Cooling SystemM1-SC-FR2-100-0M1-SC-FR2-100-02022-02-01
00850019947007Dermal Cooling SystemC2-001M1-CO-120-002021-03-31
00850019947014Dermal Cooling SystemHP-005M1-HP-007-002021-03-31
00850019947182Dermal Cooling SystemM1-SC-FR1-100-1M1-SC-FR1-100-12021-03-31
B563HP0040Dermal Cooling SystemHP-004HP-0042019-08-20
B563HP0050Dermal Cooling SystemHP-005HP-0052020-07-07
B563C20010Dermal Cooling SystemC2-001C2-0012017-08-22
B563HP0020Dermal Cooling SystemHP-002HP-0022018-05-09
B563HP0030Dermal Cooling SystemHP-003HP-0032018-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00812120004895Game Ready* SystemAvanos Medical, Inc.ILO2026-07-31
00812120005076Game Ready* Full Leg Boot Wrap, MediumAvanos Medical, Inc.ILO2026-07-31
00812120005113Game Ready* Ankle Wrap, LargeAvanos Medical, Inc.ILO2026-07-31
00812120005120Game Ready* Ankle Wrap, Extra LargeAvanos Medical, Inc.ILO2026-07-31
00812120005137Game Ready* Shoulder Wrap, Medium, RightAvanos Medical, Inc.ILO2026-07-31
00812120005144Game Ready* Shoulder Wrap, Medium, LeftAvanos Medical, Inc.ILO2026-07-31
00812120005151Game Ready* Shoulder Wrap, Large, RightAvanos Medical, Inc.ILO2026-07-31
00812120005168Game Ready* Shoulder Wrap, Large, LeftAvanos Medical, Inc.ILO2026-07-31
00812120005175Game Ready* Back WrapAvanos Medical, Inc.ILO2026-07-31
00812120005182Game Ready* C-T Spine Wrap, LargeAvanos Medical, Inc.ILO2026-07-31
00812120005199Game Ready* Hip/Groin Wrap, RightAvanos Medical, Inc.ILO2026-07-31
00812120005205Game Ready* Hip/Groin Wrap, LeftAvanos Medical, Inc.ILO2026-07-31
00812120005212Game Ready* Hand/Wrist WrapAvanos Medical, Inc.ILO2026-07-31
00812120005229Game Ready* Flexed Elbow WrapAvanos Medical, Inc.ILO2026-07-31
00812120005236Game Ready* Half Leg Boot WrapAvanos Medical, Inc.ILO2026-07-31
00812120005243Game Ready* Full Leg Boot Wrap, LargeAvanos Medical, Inc.ILO2026-07-31
00812120005250Game Ready* Straight Knee SleeveAvanos Medical, Inc.ILO2026-07-31
00812120005267Game Ready* Articulated Knee SleeveAvanos Medical, Inc.ILO2026-07-31
00812120005274Game Ready* Straight Elbow SleeveAvanos Medical, Inc.ILO2026-07-31
00812120005281Game Ready* Ankle Sleeve, LargeAvanos Medical, Inc.ILO2026-07-31
00812120005298Game Ready* Ankle Sleeve, Extra LargeAvanos Medical, Inc.ILO2026-07-31
00812120005304Game Ready* Shoulder Sleeve, Medium, RightAvanos Medical, Inc.ILO2026-07-31
00812120005311Game Ready* Shoulder Sleeve, Medium, LeftAvanos Medical, Inc.ILO2026-07-31
00812120005328Game Ready* Shoulder Sleeve, Large, RightAvanos Medical, Inc.ILO2026-07-31
00812120005335Game Ready* Shoulder Sleeve, Large, LeftAvanos Medical, Inc.ILO2026-07-31
00812120005342Game Ready* Back SleeveAvanos Medical, Inc.ILO2026-07-31
00812120005359Game Ready* C-T Spine Sleeve, LargeAvanos Medical, Inc.ILO2026-07-31
00812120005366Game Ready* Hip/Groin Sleeve, RightAvanos Medical, Inc.ILO2026-07-31
00812120005373Game Ready* Hip/Groin Sleeve, LeftAvanos Medical, Inc.ILO2026-07-31
00812120005380Game Ready* Hand/Wrist SleeveAvanos Medical, Inc.ILO2026-07-31