FDA.reportPublic FDA data

Dermal Cooling System

Primary DI
00850019947847
Brand
Dermal Cooling System
Company
R2 Technologies, Inc.
Model
M1-TIP3-10
Catalog number
M1-TIP3-10
Device description
Dermal Cooling System dermabrasion 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
GEDBRUSH, DERMABRASION, MANUAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEDBrush, Dermabrasion, ManualGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850019947847PrimaryGS10
00850019947632Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850019947847008500199478478500199478470850019947847
00850019947632008500199476328500199476320850019947632

GMDN Terms#

Term, Definition table
TermDefinition
Dermabrasion brush, manualA hand-operated device with wire bristles that is used to manually plane the skin (surgical removal of the epidermis and as much of the dermis as necessary) to remove scars, tattoos, pigmented nevi, fine wrinkles, or other irregularities. This is a reusable device.

Contacts#

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

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850019947564Dermal Cooling SystemM1-TIP1-10M1-TIP1-102023-06-09
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
10197344029686MEDLINEMEDLINE INDUSTRIES, INC.GED2024-07-11
30197344029680MEDLINEMEDLINE INDUSTRIES, INC.GED2024-07-11
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00630094188263Bioseal Inc.BIOSEALGED2023-10-05
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00630094188409Bioseal Inc.BIOSEALGED2023-10-05
00630094188706Bioseal Inc.BIOSEALGED2023-10-05
00630094188904Bioseal Inc.BIOSEALGED2023-10-05
00630094188911Bioseal Inc.BIOSEALGED2023-10-05
00630094188928Bioseal Inc.BIOSEALGED2023-10-05
00630094188935Bioseal Inc.BIOSEALGED2023-10-05
10630094188253Bioseal Inc.BIOSEALGED2023-10-05
10630094188260Bioseal Inc.BIOSEALGED2023-10-05
10630094188307Bioseal Inc.BIOSEALGED2023-10-05
10630094188406Bioseal Inc.BIOSEALGED2023-10-05
10630094188703Bioseal Inc.BIOSEALGED2023-10-05
10630094188901Bioseal Inc.BIOSEALGED2023-10-05
10630094188918Bioseal Inc.BIOSEALGED2023-10-05
10630094188925Bioseal Inc.BIOSEALGED2023-10-05
10630094188932Bioseal Inc.BIOSEALGED2023-10-05
00850019947878Dermal Cooling SystemR2 Technologies, Inc.GED2023-06-09
00850019947632Dermal Cooling SystemR2 DERMATOLOGY INC.GED2023-06-09
B7687834600Buxton BioMedicalBuxton Biomedical IncGED2023-01-10
00827002485273CookCOOK INCORPORATEDGED2020-10-02
00860371002306Norsen Debrider, SterileBEL-MED, INC.GED2019-05-29