Alpha™ Press Needles

Basic Information

• Brand Name: Alpha™ Press Needles
• Primary DI: 00818318028032
• Version / Model: 0.22 x 1.3 mm
• Catalog Number: NP1-22
• Company Name: Prime Holly Corporation
• Labeler DUNS: 080445043
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2025-01-04
• Public Version: 1
• Public Version Date: 2025-01-13
• Public Version Status: New
• Public Device Record Key: 12e00ba0-3841-4e37-bc8e-66b4c2ca86ac

Device Description

Needles are individually packaged in sterile, tamper-evident blister packs with a plastic case and sheath to prevent contact with the needle and tape.

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	10818318028039	GS1		50	In Commercial Distribution
Primary	00818318028032	GS1
Unit of Use	20818318028036	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			0.22 x 1.3 mm