TCMzoneHuaTuo

Basic Information

• Brand Name: TCMzoneHuaTuo
• Primary DI: 00810202811409
• Version / Model: TCL Type 0.35mm x 100mm
• Company Name: TCMZone, LLC
• Labeler DUNS: 007842633
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2025-08-12
• Public Version: 1
• Public Version Date: 2025-08-20
• Public Version Status: New
• Public Device Record Key: cab702a0-4ab6-4c03-b23e-76f35ff26c43

Device Description

TCL Type Acupuncture Needle 0.35mm x 100mm Copper and Loop Handle 1 needle per tube 100needles/box

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	00810202811416	GS1
Primary	00810202811409	GS1