FDA UDI
In Commercial Distribution
🇺🇸 United States
Pretika
DI: 00813859002886
·
Model: ST288
·
PRETIKA CORPORATION
Product Codes
3
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Pretika
- Primary DI
- 00813859002886
- Version / Model
- ST288
- Catalog Number
- ST288
- 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
- a023ac56-cf89-4268-adaa-2b9f43ad3bab
Device Description
SonicLift 2.0
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NFO | Stimulator, transcutaneous electrical, aesthetic purposes | Neurology | 882.5890 | 2 |
| IRO | VIBRATOR, THERAPEUTIC | Physical Medicine | 890.5975 | 1 |
| GET | MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED | General, Plastic Surgery | 878.4820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35751 | Transcutaneous electrical stimulation lead | A non-sterile, insulated, electrical conducting wire intended to be used to connect a transcutaneous electrical stimulation electrode to an electrical stimulus generator (e.g., TENS system generator), or a wire having a distal end that splits and terminates as electrodes which are placed on the patient for the transmission of electrical stimulation. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20813859002880 | GS1 | Master Carton | 3 | In Commercial Distribution | |
| Package | 10813859002883 | GS1 | Kit | 2 | In Commercial Distribution | |
| Primary | 00813859002886 | GS1 |
Customer Contacts
- Phone
- +1(949)488-8818 ext. 101
- [email protected]