SEIRIN ACUPUNCTURE NEEDLE

Basic Information

• Brand Name: SEIRIN ACUPUNCTURE NEEDLE
• Primary DI: 04547248140205
• Version / Model: ELIPEAS No.3(0.20)x7mm
• Company Name: SEIRIN CORPORATION
• Labeler DUNS: 693307373
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2021-08-25
• Public Version: 1
• Public Version Date: 2021-09-02
• Public Version Status: New
• Public Device Record Key: 0e07e27e-9fb5-408c-81ab-f4f5c81d1e3d

Device Description

ELIPEAS is perfect for facial, auricular acupuncture especially treating the body parts where needles inserted superficially. Stabled needle retention with less-weighed-handle. ELIPEAS is available only in a length of 7mm and does not have guide tubes, which makes it ideal for freehand techniques. 4 needles per plastic case. This plastic case not only preserves the needle but also converts into both standing and portable functional dispenser by folding it. The color-coded 18 mm plastic handle gives the practitioner a secure grip. Box of 100 sterile, disposable needles.

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
MQX	Needle, Acupuncture, Single Use	General Hospital	880.5580	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34175	Acupuncture needle, single-use	A sterile, long, slender, sharply-pointed instrument used to stimulate peripheral nerves in order to produce surgical anaesthesia, relieve pain, and to promote other therapeutic effects. It is widely used in complementary therapy. 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	24547248140209	GS1
Primary	04547248140205	GS1
Package	14547248140202	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	7	Millimeter