AcuTek Gold-Plated Acupuncture Needle

Basic Information

• Brand Name: AcuTek Gold-Plated Acupuncture Needle
• Primary DI: 00831592003250
• Version / Model: A-1G 0.25 X 40
• Company Name: UPC MEDICAL SUPPLIES, INC.
• Labeler DUNS: 942011719
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2017-12-11
• Public Version: 6
• Public Version Date: 2024-01-31
• Public Version Status: Update
• Public Device Record Key: 514fa9e3-fd11-4897-8fa0-363d2bd0aa39
• Distribution End Date: 2024-01-31

Device Description

AcuTek Spring Handle Bulk 10 Acupuncture Needle is well known for its smooth and painless insertion. It is one of the best acupuncture needles in the U.S.

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: 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
Primary	00831592003250	GS1
Unit of Use	00008315920000	GS1

Premarket Submissions

Submission Number	Supplement Number
K974122	000

Device Sizes

Type	Value	Unit	Text
Length	40	Millimeter
Outer Diameter	0.25	Millimeter