Tai Chi™ Single

Basic Information

• Brand Name: Tai Chi™ Single
• Primary DI: 16970514320332
• Version / Model: AY6046
• Catalog Number: AY6046
• 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: 9e88c113-8ebb-4dbf-89d5-0fe361512fd9

Device Description

Sterile, disposable, surgical stainless steel Chinese style acupuncture needles with spiral wound silver plated copper handle. One needle with one insertion tube per sterile, individually sealed blister package. Box of 100, 0.30 x 125mm.

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	36970514320336	GS1	Case	10	In Commercial Distribution
Primary	16970514320332	GS1
Unit of Use	06970514320335	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			0.30 x 125mm