SEIRIN Shonishin

Basic Information

• Brand Name: SEIRIN Shonishin
• Primary DI: 04547248600013
• Version / Model: SEIRIN Shonishin
• Company Name: SEIRIN CORPORATION
• Labeler DUNS: 693307373
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2018-06-28
• Public Version: 2
• Public Version Date: 2019-02-22
• Public Version Status: Update
• Public Device Record Key: 8fe49472-75be-4b1f-bfba-6482f165940c

Device Description

Single use, sterile shonishin with 4 different surfaces for point stimulation.

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
64144	Acupressure applicator, reusable	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 made of polymer materials and is supplied in a variety of shapes and sizes with differently shaped contact points; it is typically held on the skin with slight manual pressure. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	14547248600010	GS1	BOX	1	In Commercial Distribution
Primary	04547248600013	GS1
Unit of Use	24547248600017	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]