SEIRIN ACUPUNCTURE NEEDLE

Basic Information

• Brand Name: SEIRIN ACUPUNCTURE NEEDLE
• Primary DI: 04547248210236
• Version / Model: L-Type No.3(0.20)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: 2e1e5bc3-a649-47e9-83a6-994e92d2ff8d

Device Description

The Laser sharp L-Type needles from SEIRIN offer practitioners a painless choice for moxibustion or electro-therapy treatments. The L-Type features a flexible 1.3 x 20 mm metal spring type handle, optimal for conducting electricity and heat during use. It also provides the practitioner with an enhanced grip, for a precise treatment. Made up entirely of surgical stainless steel, the L-Type upholds SEIRIN's long tradition of innovation, quality, and safety. Each needle comes individually packaged with its own polypropylene guide tube, which is rounded on the end for patient comfort and is 100% PVC free. 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	14547248210233	GS1	BOX	10	In Commercial Distribution
Primary	04547248210236	GS1
Unit of Use	24547248210230	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	50	Millimeter
Outer Diameter	0.20	Millimeter