Acufast The Earth Friendly Needle

Basic Information

• Brand Name: Acufast The Earth Friendly Needle
• Primary DI: 00754028820156
• Version / Model: ANS20-1520GAS C
• Catalog Number: AFSC2015
• Company Name: Eastern Currents Distributing Ltd
• Labeler DUNS: 257053454
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1000
• Record Status: Published
• Publish Date: 2020-11-25
• Public Version: 1
• Public Version Date: 2020-12-03
• Public Version Status: New
• Public Device Record Key: d7d4f3c2-40e6-400f-a817-4674cddf5e5c

Device Description

Acufast needles are the world’s first consciously produced environmentally friendly acupuncture needle brand. The manufacturer has chosen low impact metals, reduced packaging sizes, used repurposed biodegradable materials for outer packages. These plus other features make this an exciting product for both ease insertion, performance, and reduction of waste. The needles are Spring handle style needles made from surgical grade stainless steel. They are machine sharpened for precision tips and are partially coated with medical grade silicone for a very smooth insertion. Acufast needles come vacuum sealed in pouch packs of 10 per pouch. There are 100 pouches with at total of 1000 needles in each box. Please note that tubes sold separately (no more wasted tubes).

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: Yes
• 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
Package	10754028820153	GS1	Case	10	In Commercial Distribution
Primary	00754028820156	GS1
Package	20754028820150	GS1	Carton	10	In Commercial Distribution
Unit of Use	07540288201568	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			0.16 mm x 40 mm