FDA.reportPublic FDA data

Pretika

Primary DI
20813859002811
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
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
ISAMassager, therapeutic, electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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.

Sterilization Methods#

Method table
Method

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
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
00813859002817PretikaST281ST2812020-04-30
00813859002886PretikaST288ST2882020-04-30
00813859002893PretikaST289ST2892020-04-30
00813859002909PretikaST290ST2902020-04-30
10813859001022PretikaST102ST1022020-04-30
10813859002746PretikaHA274HA2742020-04-30
20813859002880PretikaST288ST2882020-04-30
20813859002897PretikaST289ST2892020-04-30
10813859002906PretikaST290ST2902020-04-30

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Primary DI, Brand, Company table
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