HWATO Yuezhen

Basic Information

• Brand Name: HWATO Yuezhen
• Primary DI: 16901452600569
• Version / Model: 0.22 x 40
• Company Name: Suzhou Medical Appliance Factory
• Labeler DUNS: 653739474
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2017-01-26
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: dee60b03-f276-4c53-9bb0-20bade594bb1

Device Description

HWATO Yuezhen acupuncture needles, sterile, disposable, and surgical stainless steel Acupuncture Needles with spring style stainless steel handle. One needle with one insertion tube per sterile, individually sealed 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: 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	36901452600563	GS1		100	In Commercial Distribution
Primary	16901452600569	GS1
Unit of Use	06901452600562	GS1

Premarket Submissions

Submission Number	Supplement Number
K974122	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			0.22x40mm