Alpha™ Acupuncture Needles

Basic Information

• Brand Name: Alpha™ Acupuncture Needles
• Primary DI: 00818318025321
• Version / Model: Y1 Type 0.48 x 50 mm
• Catalog Number: NAY1-4820
• Company Name: Prime Holly Corporation
• Labeler DUNS: 080445043
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2022-01-24
• Public Version: 3
• Public Version Date: 2023-11-08
• Public Version Status: Update
• Public Device Record Key: 7393f370-9738-4590-b780-66d578c86f2f

Device Description

Surgical stainless steel, Plastic handle, High-tensile surgical stainless steel body, Comfortable needle for patients.

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
Package	10818318025328	GS1		50	In Commercial Distribution
Primary	00818318025321	GS1
Unit of Use	20818318025325	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			0.48 x 50 mm