FDA.reportPublic FDA data

Pretika

Primary DI
20813859002897
Brand
Pretika
Company
PRETIKA CORPORATION
Model
ST289
Catalog number
ST289
Device description
SonicDermabrasion 2.0
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
10813859002890PackageGS12In Commercial Distribution
20813859002897PackageGS13In Commercial Distribution
00813859002893PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081385900289010813859002890
2081385900289720813859002897
00813859002893008138590028938138590028930813859002893

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
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
20813859002811PretikaST281ST2812020-04-30
20813859002880PretikaST288ST2882020-04-30
10813859002906PretikaST290ST2902020-04-30

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Primary DI, Brand, Company table
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