FDA.reportPublic FDA data

SST Pro

Primary DI
08800066110017
Brand
SST Pro
Company
SeoulinMedicare Co.,Ltd.
Model
SLM-1001
Published
2022-05-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEYMotor, Surgical Instrument, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEYMotor, Surgical Instrument, Ac-PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800066110017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800066110017088000661100178800066110017

GMDN Terms#

Term, Definition table
TermDefinition
Hair extraction punchA hollow, shaft-like, manually-operated, surgical instrument intended to be used during a hair transplantation procedure to extract small plugs of donor skin containing hair follicles [follicular unit extraction (FUE)] and may also be used to create holes at the site where the plugs are to be transplanted; it is not an automated or robotic instrument. This is a reusable device.

Regulatory Flags#

DUNS number
688896704
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
08800066110024N-DERMSLM-10012022-06-07
08800066100056SST Pro TipSST Pro Tip 0.32022-05-27
08800066100063SST Pro TipSST Pro Tip 0.42022-05-27
08800066100070SST Pro TipSST Pro Tip 0.52022-05-27
08800066100087SST Pro TipSST Pro Tip 0.62022-05-27
08800066100094SST Pro TipSST Pro Tip 0.82022-05-27
08800066100100SST Pro TipSST Pro Tip 1.02022-05-27
08800066170035ProfacialSLM-7654E2022-05-27
08800066190026PlasonSLM-96002022-05-27
08809540050023Plasma showerSLM-90022022-05-27

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20845854041342CONMEDConmed CorporationGEY2023-09-01
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00814334022207NARichard Wolf GmbHGEY2022-12-27