FDA UDI
In Commercial Distribution
🇺🇸 United States
Umitec
DI: 06950940802377
·
Model: AST-805B
·
Shenzhen Osto Technology Co.,Ltd.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1000
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Umitec
- Primary DI
- 06950940802377
- Version / Model
- AST-805B
- Company Name
- Shenzhen Osto Technology Co.,Ltd.
- Labeler DUNS
- 528161684
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1000
- Record Status
- Published
- Publish Date
- 2025-01-30
- Public Version
- 1
- Public Version Date
- 2025-02-07
- Public Version Status
- New
- Public Device Record Key
- ca8860d2-709f-4a7c-91a0-e96516404f82
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- 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 |
|---|---|---|---|---|
| OLP | Over-The-Counter Powered Light Based Laser For Acne | General, Plastic Surgery | 878.4810 | 2 |
| OHS | Light Based Over The Counter Wrinkle Reduction | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13763 | Acupuncture electrical stimulation system | An electrically-powered unit designed to be used specifically to apply electrical stimuli to acupuncture sites (electroacupuncture). It is an external low-intensity, low frequency pulse (usually 1 to 100 pulses per second), multimode generator intended to connect to acupuncture electrodes. The electrodes may be placed either on the skin, or through acupuncture needles that penetrate the skin at the acupuncture points. Some may use a probe to detect the acupuncture sites using visual or audio signals. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 06950940802384 | GS1 | ||||
| Primary | 06950940802377 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K213056 | 000 |