SEIRIN ACUPUNCTURE NEEDLE

Basic Information

• Brand Name: SEIRIN ACUPUNCTURE NEEDLE
• Primary DI: 04547248230135
• Version / Model: M-Type No.1(0.16)x50mm
• Company Name: SEIRIN CORPORATION
• Labeler DUNS: 693307373
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2016-12-19
• Public Version: 3
• Public Version Date: 2018-06-04
• Public Version Status: Update
• Public Device Record Key: 64a3047e-3ef2-4641-b5b7-fe4d49f2c24c

Device Description

The M-Type needle from Seirin has a plain metal handle, in contrast to the coiled metal handle of the L-Type, and is made entirely of stainless steel. There is no holding tab. Seirin has ingeniously adapted the Click-Push System to these incredible metal handle needles. The handle is 5mm longer than that of the L-Type for ease of needle manipulation. The M-Type also includes guide tubes with a thinner internal diameter of reduce play between the handle and tube upon insertion, plus softer plastic guide tubes to make it easier to insert needles at an angle. M-Type needles are perfectly suited to electro-acupuncture and moxibustion. 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
Package	14547248230132	GS1	BOX	10	In Commercial Distribution
Primary	04547248230135	GS1
Unit of Use	24547248230139	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	50	Millimeter
Outer Diameter	0.16	Millimeter