Tai Chi™ Power 80

Basic Information

• Brand Name: Tai Chi™ Power 80
• Primary DI: 16970514320103
• Version / Model: AY7110
• Catalog Number: AY7110
• Company Name: Suzhou Shenlong Medical Apparatus Co., Ltd.
• Labeler DUNS: 545745192
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 80
• Record Status: Published
• Publish Date: 2016-07-22
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 1e11a424-671d-4165-a870-2c805168e102

Device Description

Painless Tai Chi™ needles, in economical bulk packaging. Made of surgical stainless steel, Tai Chi™ Power 80 needles provide practitioners with a high quality needle at an affordable price. The flexible "spring" style metal handle provides superior grip for the practitioner, while the advanced manufacturing process provides a painless experience for the patient. Each easy-open plastic package contains eight sterile acupuncture needles with one insertion tube. Box of 80 needles, 0.25 x 40 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	36970514320107	GS1	Case	10	In Commercial Distribution
Primary	16970514320103	GS1
Unit of Use	06970514320106	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 40 mm