FDA UDI
In Commercial Distribution
🇺🇸 United States
Cupping Device
DI: 06974581810072
·
Model: uCute-2500A
·
ShenZhen Pentasmart Technology Co,.Ltd
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Cupping Device
- Primary DI
- 06974581810072
- Version / Model
- uCute-2500A
- Company Name
- ShenZhen Pentasmart Technology Co,.Ltd
- Labeler DUNS
- 551250083
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-07-20
- Public Version
- 1
- Public Version Date
- 2021-07-28
- Public Version Status
- New
- Public Device Record Key
- c0228040-fbe3-43fc-8482-7a5290171885
Device Description
Device, Pressure Applying
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| KNM | Device, Pressure Applying | Physical Medicine | 890.5765 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64144 | Acupressure applicator, reusable | A small device intended for the application of noninvasive, non-powered acupressure to acupuncture points on the skin for the treatment of a variety of conditions/disorders. It is made of polymer materials and is supplied in a variety of shapes and sizes with differently shaped contact points; it is typically held on the skin with slight manual pressure. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06974581810072 | GS1 |