FDA UDI
In Commercial Distribution
🇺🇸 United States
Pretika
DI: 00813859002817
·
Model: ST281
·
PRETIKA CORPORATION
Product Codes
3
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Pretika
- Primary DI
- 00813859002817
- Version / Model
- ST281
- Catalog Number
- ST281
- Company Name
- PRETIKA CORPORATION
- Labeler DUNS
- 848304379
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-04-30
- Public Version
- 1
- Public Version Date
- 2020-05-08
- Public Version Status
- New
- Public Device Record Key
- fd0b82c5-c60b-4a98-a65f-59f230c62a20
Device Description
SonicDermabrasion® Pro Series
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ISA | Massager, therapeutic, electric | Physical Medicine | 890.5660 | 1 |
| GFE | Brush, dermabrasion, powered | General, Plastic Surgery | 878.4820 | 1 |
| GET | MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED | General, Plastic Surgery | 878.4820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64428 | Ultrasonic skin surface treatment unit | An 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20813859002811 | GS1 | Master Carton | 3 | In Commercial Distribution | |
| Package | 10813859002814 | GS1 | Box | 2 | In Commercial Distribution | |
| Primary | 00813859002817 | GS1 |
Customer Contacts
- Phone
- +1(949)488-8818 ext. 101
- [email protected]