TCMzone HuoTuo

Basic Information

• Brand Name: TCMzone HuoTuo
• Primary DI: 00860014142437
• Version / Model: T1K-0.20mm x 40mm
• Catalog Number: T1K-0.20mm x 40mm (#36)
• Company Name: TCMZone, LLC
• Labeler DUNS: 007842633
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1000
• Record Status: Published
• Publish Date: 2025-06-30
• Public Version: 1
• Public Version Date: 2025-07-08
• Public Version Status: New
• Public Device Record Key: 2a84e8a6-87e7-41c9-85fe-0cee0f741526

Device Description

Disposable acupuncture needle, 0.20mm × 40mm (#36), with spring handle and guide tube. Sterile, single-use. Packaged 10 needles per blister, 100 blisters per box (1000 needles total).

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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
Unit of Use	00860014142475	GS1
Primary	00860014142437	GS1