STERILE ACUPUNCTURE NEEDLES FOR SINGLE USE

Basic Information

• Brand Name: STERILE ACUPUNCTURE NEEDLES FOR SINGLE USE
• Primary DI: 06971685274168
• Version / Model: 0.20*25
• Company Name: Changchun AIK Medical Devices Co., Ltd.
• Labeler DUNS: 543439762
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 500
• Record Status: Published
• Publish Date: 2019-09-30
• Public Version: 1
• Public Version Date: 2019-10-08
• Public Version Status: New
• Public Device Record Key: 4672d995-a9e3-40ec-ae3d-7c0dd79770d7

Device Description

The AIK Sterile Acupuncture Needles are manufactured from stainless steel and sterilized by gamma-rays radiation. Ten needles with one tube per sterile, individually packed a pouch, 500 needles per box.

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	06971685274168	GS1
Unit of Use	16971685272093	GS1

Premarket Submissions

Submission Number	Supplement Number
K162566	000