FDA.reportPublic FDA data

MINIVAC

Primary DI
B366VA16120
Brand
MINIVAC
Company
Ecleris
Model
R00
Catalog number
VA16120
Device description
MINIVAC
Published
2023-06-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GFEBrush, Dermabrasion, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFEBrush, Dermabrasion, PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B366VA16120PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Skin abrasion unitA mains electricity (AC-powered) device used for the removal of the skin surface by abrasion (applied by some kind of rotating abrasive tool, e.g., a wire brush or emery disc). It may be used during plastic surgery and can be used for treatments such as the removal of scars, tattoos, pigmented nevi, fine wrinkles, or other irregularities of the skin. This GMDN code may reflect old technology.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity35 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-30 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
786-483-7490ytzielo@ecleris.com

Regulatory Flags#

DUNS number
043555079
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B366U1VI360R04Procam HD CMOS IIR04U1VI3602026-05-27
B366U1VI3605PROCAM 4K USBRX1VI360/52026-05-19
B366LED0204R00PORTALEDR00LED020/42026-02-11
B366U1C200FR01MICROSCOPE ColposcopeR01U1C200F2024-02-13
B366U1C200TR01MICROSCOPE ColposcopeR01U1C200T2024-02-13
B366U1C200WR01MICROSCOPE ColposcopeR01U1C200W2024-02-13
B366HC200AR00MICROSCOPE ColposcopeR00HC200A2024-11-27
B366U1C200AR00MICROSCOPE ColposcopeR00U1C200A2024-11-25
B366U1C200FR00MICROSCOPE ColposcopeR00U1C200F2024-02-07
B366U1C200TR00MICROSCOPE ColposcopeR00U1C200T2024-02-07
B366U1C200WR00MICROSCOPE ColposcopeR00U1C200W2024-02-07
B366MC400MICROSTAR ColposcopeR02MC4002023-08-22
B366MC410MICROSTAR ColposcopeR00MC4102023-08-22
B366C100FHD1MICROSTAR ColposcopeR00C100FHD12023-08-18
B366SN0300140SinuscopeR00SN03001402023-08-18
B366SN0330140SinuscopeR00SN03301402023-08-18
B366SN0370140SinuscopeR00SN03701402023-08-18
B366SN0400175SinuscopeR00SN04001752023-08-18
B366SN0430175SinuscopeR00SN04301752023-08-18
B366SN0445175SinuscopeR00SN04451752023-08-18

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Primary DI, Brand, Company table
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08053782383733T-FACEB&M SRL MARKETING NEL BENESSEREGFE2026-03-25
00810007534794Hydrafacial™ Elite System, 240V INTERNATIONALHydrafacial LLCGFE2026-03-13
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