Identity
- Trade Name
- SEIRIN PY-Zero FDA UDI
- Generic Name
- Acupressure applicator, single-use FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- PY-Zero 0.3mm Ø9 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547248423063 FDA UDI
- FDA Product Code
- KNM FDA UDI
- GMDN Term
- Acupressure applicator, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5765 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 0.20 Millimeter FDA UDILength — 0.3 Millimeter FDA UDI
Category: Acupressure applicator, single-use
SEIRIN PY-Zero by Seirin Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Acupressure applicator, single-use.
- SEIRIN PY-Zero — SEIRIN CORPORATION · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Seirin Corporation
Sources (1)
- FDA UDI cd7ad851-b01a-4399-8ba1-cee42c808ddf 35 fields · synced May 31, 2026