AcuBEST Acupuncture Needles

Basic Information

• Brand Name: AcuBEST Acupuncture Needles
• Primary DI: B465A1362501
• Version / Model: A1-36-250
• Company Name: A & A MEDICAL SUPPLIES INC.
• Labeler DUNS: 801197380
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2017-01-19
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 7748dbc6-f0e5-46d1-b2e5-f127b1b2c95c

Device Description

Painless, disposable and sterile, AcuBEST acupuncture needles are made of high quality surgical stainless steel with spiral-wound handles. These single-use needles are engineered to be sharp for a smooth insertion. One needle with one (insertion) guide tube per sterile, individually sealed blister package. Box of 100 needles. 0.20mm x 65mm (36# x 2.5").

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	B465A1362501	HIBCC
Unit of Use	B465A1362500	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Needle Size 0.20mm x 65mm