FDA UDI
In Commercial Distribution
🇺🇸 United States
SEIRIN PYONEX
DI: 04547248423025
·
Model: Pyonex Zero Violet 0.20x0.3mm Ø9
·
SEIRIN CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- SEIRIN PYONEX
- Primary DI
- 04547248423025
- Version / Model
- Pyonex Zero Violet 0.20x0.3mm Ø9
- Company Name
- SEIRIN CORPORATION
- Labeler DUNS
- 693307373
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2018-05-24
- Public Version
- 3
- Public Version Date
- 2019-02-22
- Public Version Status
- Update
- Public Device Record Key
- b1880ede-1128-4a3d-b35c-adeca0abdcdd
Device Description
Designed with both the patient and practitioner in mind, the new and advanced Pyonex™ Singles continue SEIRIN's tradition of gentle, painless and stress free press needles. The patented plastic case and sheath allow the practitioner to insert the needle without touching the needle tip or the surface of the Micropore adhesive tape. This hypoallergenic latex-free adhesive allows the skin to breathe during treatment. No needle tip. The stimulation by pressing.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 64143 | Acupressure applicator, single-use | 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 typically a polymer disc with a very short protruding metallic contact point, held on the skin with slight manual pressure. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 14547248423022 | GS1 | BOX | 10 | In Commercial Distribution | |
| Primary | 04547248423025 | GS1 | ||||
| Unit of Use | 24547248423029 | GS1 |
Customer Contacts
- Phone
- 800 722 8775
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 0.20 | Millimeter | |
| Length | 0.3 | Millimeter | |
| Device Size Text, specify | adhesive tape diameter 9mm |