FDA.reportPublic FDA data

Pretika

Primary DI
00813859002817
Brand
Pretika
Company
PRETIKA CORPORATION
Model
ST281
Catalog number
ST281
Device description
SonicDermabrasion® Pro Series
Published
2020-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GETMOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED
GFEBrush, dermabrasion, powered
ISAMassager, therapeutic, electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GETMotor, Surgical Instrument, Pneumatic PoweredGeneral, Plastic Surgery1
GFEBrush, Dermabrasion, PoweredGeneral, Plastic Surgery1
ISAMassager, Therapeutic, ElectricPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10813859002814PackageGS12In Commercial Distribution
20813859002811PackageGS13In Commercial Distribution
00813859002817PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081385900281410813859002814
2081385900281120813859002811
00813859002817008138590028178138590028170813859002817

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic skin surface treatment unitAn electrically-powered, hand-held device intended to apply ultrasonic vibration to the skin surface, typically the face, for treatment of acne and/or for deep cleansing. It is used in timed sessions where the vibrational energy is intended to open and unclog skin pores. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
+1(949)488-8818thomasnichols@pretika.com

Regulatory Flags#

DUNS number
848304379
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813859001483PretikaST148ST1482021-02-19
10813859001480PretikaST148ST1482021-02-19
00813859002619PretikaST261ST2612019-07-01
00813859001025PretikaST102ST1022020-04-30
00813859002749PretikaHA274HA2742020-04-30
00813859002886PretikaST288ST2882020-04-30
00813859002893PretikaST289ST2892020-04-30
00813859002909PretikaST290ST2902020-04-30
10813859001022PretikaST102ST1022020-04-30
10813859002746PretikaHA274HA2742020-04-30
20813859002811PretikaST281ST2812020-04-30
20813859002880PretikaST288ST2882020-04-30
20813859002897PretikaST289ST2892020-04-30
10813859002906PretikaST290ST2902020-04-30

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