SEIRIN PY-Zero

GUDID 14547248423053

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.

SEIRIN CORPORATION

Acupressure applicator, single-use

• Primary Device ID: 14547248423053
• NIH Device Record Key: 225ce934-6118-4e79-a966-a5be53bb3439
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SEIRIN PY-Zero
• Version Model Number: PY-Zero 0.3mm
• Company DUNS: 693307373
• Company Name: SEIRIN CORPORATION
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800 722 8775
• Email: customerservice@lhasaoms.com
• Phone: 800 722 8775
• Email: customerservice@lhasaoms.com
• Phone: 800 722 8775
• Email: customerservice@lhasaoms.com
• Phone: 800 722 8775
• Email: customerservice@lhasaoms.com
• Phone: 800 722 8775
• Email: customerservice@lhasaoms.com
• Phone: 800 722 8775
• Email: customerservice@lhasaoms.com
• Phone: 800 722 8775
• Email: customerservice@lhasaoms.com
• Phone: 800 722 8775
• Email: customerservice@lhasaoms.com
• Phone: 800 722 8775
• Email: customerservice@lhasaoms.com
• Phone: 800 722 8775
• Email: customerservice@lhasaoms.com
• Phone: 800 722 8775
• Email: customerservice@lhasaoms.com
• Phone: 800 722 8775
• Email: customerservice@lhasaoms.com
• Phone: 800 722 8775
• Email: customerservice@lhasaoms.com
• Phone: 800 722 8775
• Email: customerservice@lhasaoms.com
• Phone: 800 722 8775
• Email: customerservice@lhasaoms.com

Device Dimensions

• Length: 0.3 Millimeter
• Outer Diameter: 0.2 Millimeter
• Length: 0.3 Millimeter
• Outer Diameter: 0.2 Millimeter
• Length: 0.3 Millimeter
• Outer Diameter: 0.2 Millimeter
• Length: 0.3 Millimeter
• Outer Diameter: 0.2 Millimeter
• Length: 0.3 Millimeter
• Outer Diameter: 0.2 Millimeter
• Length: 0.3 Millimeter
• Outer Diameter: 0.2 Millimeter
• Length: 0.3 Millimeter
• Outer Diameter: 0.2 Millimeter
• Length: 0.3 Millimeter
• Outer Diameter: 0.2 Millimeter
• Length: 0.3 Millimeter
• Outer Diameter: 0.2 Millimeter
• Length: 0.3 Millimeter
• Outer Diameter: 0.2 Millimeter
• Length: 0.3 Millimeter
• Outer Diameter: 0.2 Millimeter
• Length: 0.3 Millimeter
• Outer Diameter: 0.2 Millimeter
• Length: 0.3 Millimeter
• Outer Diameter: 0.2 Millimeter
• Length: 0.3 Millimeter
• Outer Diameter: 0.2 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04547248423056 [Primary]
GS1	14547248423053 [Package]; Contains: 04547248423056; Package: BOX [10 Units]; In Commercial Distribution
GS1	24547248423050 [Unit of Use]

FDA Product Code

• KNM: Device, Pressure Applying

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-11
• Device Publish Date: 2025-03-03

On-Brand Devices [SEIRIN PY-Zero]

• 24547248423067: PY-Zero is a non-invasive and stress-free acupressure device that stimulates through gentle pres
• 14547248423053: PY-Zero is a non-invasive and stress-free acupressure device that stimulates through gentle pres