FDA UDI
In Commercial Distribution
🇺🇸 United States
SEIRIN PY-Zero
DI: 04547248423056
·
Model: PY-Zero 0.3mm
·
SEIRIN CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- SEIRIN PY-Zero
- Primary DI
- 04547248423056
- Version / Model
- PY-Zero 0.3mm
- Company Name
- SEIRIN CORPORATION
- Labeler DUNS
- 693307373
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2025-03-03
- Public Version
- 1
- Public Version Date
- 2025-03-11
- Public Version Status
- New
- Public Device Record Key
- 225ce934-6118-4e79-a966-a5be53bb3439
Device Description
PY-Zero is a non-invasive and stress-free acupressure device that stimulates through gentle pressing instead of a needle tip. The patented plastic case and sheath enable 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.
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 | 14547248423053 | GS1 | BOX | 10 | In Commercial Distribution | |
| Primary | 04547248423056 | GS1 | ||||
| Unit of Use | 24547248423050 | GS1 |
Customer Contacts
- Phone
- 800 722 8775
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 0.3 | Millimeter | |
| Outer Diameter | 0.20 | Millimeter |