SHENMEN

Basic Information

• Brand Name: SHENMEN
• Primary DI: B491SM1380501
• Version / Model: SM138050
• Catalog Number: SM138050
• Company Name: Wujiang City ShenLing Medical Device Co.,Ltd
• Labeler DUNS: 654613546
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2018-01-02
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 30e4b508-395d-4982-9220-5c430e845731

Device Description

Smooth and sharp for painless, SHENMEN disposable sterile acupuncture needles are made of high quality surgical stainless steel and the handle is without loop. Sterilized with Ethylene Oxide. Each needle is individually sealed with guide tube. 0.18mm x 13mm (38# x 0.5").

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• 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	B491SM1380503	HIBCC		100	In Commercial Distribution
Primary	B491SM1380501	HIBCC
Unit of Use	B491SM1380500	HIBCC

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Needle Size 0.18mm x 13mm