AcuSTAR Acupuncture Needles

Basic Information

• Brand Name: AcuSTAR Acupuncture Needles
• Primary DI: B465A2S301005
• Version / Model: A2S-30-100
• Company Name: A & A MEDICAL SUPPLIES INC.
• Labeler DUNS: 801197380
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1000
• Record Status: Published
• Publish Date: 2017-08-10
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 3e6e0548-27de-4248-80d8-c449733c20d8

Device Description

Produced with high-quality surgical stainless steel, AcuSTAR acupuncture needles are designed for smooth and painless insertion. These Korean-type needles are sterile, disposable, single-use needles with spiral-wound handles. Ten needles with one (insertion) guide tube per sterile, individually sealed blister package. Box of 1000 needles. 0.30mm x 30mm (30# x 1.0").

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: 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	B465A2S301005	HIBCC
Unit of Use	B465A2S301000	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Needle Size 0.30mm x 30mm