Master Tai Chi™

Basic Information

• Brand Name: Master Tai Chi™
• Primary DI: 16970514320578
• Version / Model: AY8346
• Catalog Number: AY8346
• Company Name: Suzhou Shenlong Medical Apparatus Co., Ltd.
• Labeler DUNS: 545745192
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2016-07-26
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: e3f56e91-173a-4d1c-aa14-bae2c6b985c2

Device Description

Sterile, disposable, surgical stainless steel Japanese style pipe type acupuncture needles with 25 mm long metal handle. Features quick-release guide tube without holding tab. One needle with one insertion tube per sterile, individually sealed blister package. Box of 100, 0.25 x 13 mm.

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: No
• 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	36970514320572	GS1	Case	10	In Commercial Distribution
Primary	16970514320578	GS1
Unit of Use	06970514320571	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K023787	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			0.25 x 13 mm