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
00197344214740MEDLINEMEDLINE INDUSTRIES, INC.ILO2026-05-15
00197344214757MEDLINEMEDLINE INDUSTRIES, INC.ILO2026-05-15
00197344214733MEDLINEMEDLINE INDUSTRIES, INC.ILO2026-05-08
00311917069159WalgreensWALGREEN CO.ILO2025-08-22
00810113577517ViveVIVE HEALTH LLCILO2024-08-20
00810041987617ViveVIVE HEALTH LLCILO2024-07-17
10850007350090Mul-T-PadC2DX, INC.ILO2024-01-09
10850007350106Mul-T-PadC2DX, INC.ILO2024-01-09
10850007350120Mul-T-PadC2DX, INC.ILO2024-01-09
20850007350073Mul-T-PadC2DX, INC.ILO2024-01-09
20850007350110T/PadC2DX, INC.ILO2024-01-09
00810041981523ViveVIVE HEALTH LLCILO2023-08-07
08809802644038CTC-7DAESUNG MAREF CO.,LTD.ILO2023-05-15
08809802644045CTC-7DAESUNG MAREF CO.,LTD.ILO2023-05-15
08809802644021CTC-7DAESUNG MAREF CO.,LTD.ILO2023-05-12
00812120001412Game Ready Articulated Knee Heat Exchanger, RentalAvanos Medical, Inc.ILO2023-04-05
00812120001429Game Ready Right Shoulder Heat Exchanger, RentalAvanos Medical, Inc.ILO2023-04-05
00812120001436Game Ready Left Shoulder Heat Exchanger, RentalAvanos Medical, Inc.ILO2023-04-05
00812120001535Game Ready Straigh Knee Wrap - DemoAvanos Medical, Inc.ILO2023-04-05
00812120001542Game Ready Articulated Knee Wrap - DemoAvanos Medical, Inc.ILO2023-04-05
00812120001566Game Ready Ankle Wrap - Large - DemoAvanos Medical, Inc.ILO2023-04-05
00812120001580Game Ready Shoulder Wrap - Medium - Right - DemoAvanos Medical, Inc.ILO2023-04-05
00812120001597Game Ready Shoulder Wrap - Medium - Left - DemoAvanos Medical, Inc.ILO2023-04-05
00812120001603Game Ready Shoulder Wrap - Large - Right - DemoAvanos Medical, Inc.ILO2023-04-05
00812120001634Game Ready C-T Spine Wrap - Large - DemoAvanos Medical, Inc.ILO2023-04-05
00812120001658Game Ready Hip/Groin Wrap - Left - DemoAvanos Medical, Inc.ILO2023-04-05
00812120001672Game Ready Flexed Elbow Wrap - DemoAvanos Medical, Inc.ILO2023-04-05
00812120002662Game Ready Med4 Elite Drain HoseAvanos Medical, Inc.ILO2023-04-05
08809802643260CTC-7DAESUNG MAREF CO.,LTD.ILO2022-05-09
00810041988126ViveVIVE HEALTH LLCILO2021-11-30