SEIRIN PY-Zero

Basic Information

• Brand Name: SEIRIN PY-Zero
• Primary DI: 04547248423063
• Version / Model: PY-Zero 0.3mm Ø9
• 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: cd7ad851-b01a-4399-8ba1-cee42c808ddf

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
Unit of Use	24547248423067	GS1
Primary	04547248423063	GS1
Package	14547248423060	GS1	BOX	10	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [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