FDA UDI
In Commercial Distribution
🇺🇸 United States
HWATO Vaccaria seed W/P-50, with Tape
DI: 16901452983860
·
Model: W/P-50 (50 PCS)
·
Suzhou Medical Appliance Factory
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
Basic Information
- Brand Name
- HWATO Vaccaria seed W/P-50, with Tape
- Primary DI
- 16901452983860
- Version / Model
- W/P-50 (50 PCS)
- Company Name
- Suzhou Medical Appliance Factory
- Labeler DUNS
- 653739474
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2023-10-10
- Public Version
- 2
- Public Version Date
- 2023-10-31
- Public Version Status
- Update
- Public Device Record Key
- 9c548cc0-5785-4338-b8f7-0b917ccf83fb
Device Description
50 Units in single pack
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
|---|---|---|---|---|
| KNM | Device, Pressure Applying | Physical Medicine | 890.5765 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45166 | Ear microsystem seed/pellet | A device used in auriculotherapy (a treatment modality in which the external surface of the ear is stimulated to alleviate pathological conditions in other parts of the body) to apply continuous pressure to stimulate meridian points. The device may be a plant seed (e.g., Vaccaria) or a metal pellet [e.g., stainless steel with or without gold (Au) or silver (Ag) plating], possibly magnetized, typically applied to the ear with adhesive tape. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 36901452983864 | GS1 | Carton | 200 | In Commercial Distribution | |
| Primary | 16901452983860 | GS1 | ||||
| Unit of Use | 06901452983863 | GS1 |