SEIRIN SPINEX NEEDLE

Basic Information

• Brand Name: SEIRIN SPINEX NEEDLE
• Primary DI: 04547248500092
• Version / Model: NS No.01(0.14)x5mm
• Company Name: SEIRIN CORPORATION
• Labeler DUNS: 693307373
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2016-09-12
• Public Version: 3
• Public Version Date: 2018-06-04
• Public Version Status: Update
• Public Device Record Key: 077b495a-67d8-4309-ab0b-ceed1054dabb

Device Description

An essential part of cosmetic acupuncture and other treatment modalities, Spinex™ intradermal needles (hinai-shin) provide you with a high quality option for specialized acupuncture treatments. These individually packaged, disposable needles are made entirely of surgical stainless steel. The heat-sealed blister package ensures sterility, while the perforated tear-off strip makes them easy to use. With a ring handle measuring 1.5mm in diameter, Spinex™ is available in 3 different lengths. To use, simply open the blister package, grip the head of the needle with tweezers, remove and insert. One sterile needle per blister package. Box of 100 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	14547248500099	GS1	BOX	10	In Commercial Distribution
Primary	04547248500092	GS1
Unit of Use	24547248500096	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	0.14	Millimeter
Length	5	Millimeter