FDA.reportPublic FDA data

Acufast The Earth Friendly Needle

Primary DI
00754028835501
Brand
Acufast The Earth Friendly Needle
Company
Eastern Currents Distributing Ltd
Model
ANS35-5025GAS C
Catalog number
AFSC3550
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 of 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).
Published
2025-08-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQXNeedle, Acupuncture, Single Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQXNeedle, Acupuncture, Single UseGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00754028835501PrimaryGS10
07540288355018Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00754028835501007540288355017540288355010754028835501
07540288355018075402883550187540288355018

GMDN Terms#

Term, Definition table
TermDefinition
Acupuncture needle, single-useA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
1-604-263-5042info@acufastneedles.com

Regulatory Flags#

DUNS number
257053454
Device count
1000
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00754028825311Acufast The Earth Friendly Needle - Non-Coated ANS25-3020GASNCAFSN25302025-08-15
00754028825410Acufast The Earth Friendly Needle - Non-Coated ANS25-4025GAS NCAFSN25402025-08-15
00754028825519Acufast The Earth Friendly Needle - Non-Coated ANS25-5025GAS NCAFSN25502025-08-15
00754028825618Acufast The Earth Friendly Needle - Non-Coated ANS25-6025GAS NCAFSN25602025-08-15
00754028830414Acufast The Earth Friendly Needle - Non-Coated ANS30-4025GAS NCAFSN30402025-08-15
00754028830513Acufast The Earth Friendly Needle - Non-Coated ANS30-5025GAS NCAFSN30502025-08-15
00754028830612Acufast The Earth Friendly Needle - Non-Coated ANS30-6025GAS NCAFSN30602025-08-15
00754028835150Acufast The Earth Friendly Needle ANS35-1520GAS CAFSC35152025-08-15
00754028835303Acufast The Earth Friendly Needle ANS35-3020GAS CAFSC35302025-08-15
00754028835402Acufast The Earth Friendly Needle ANS35-4025GAS CAFSC35402025-08-15
00754028835419Acufast The Earth Friendly Needle - Non-Coated ANS35-4025GAS NCAFSN35402025-08-15
00754028835518Acufast The Earth Friendly Needle - Non-Coated ANS35-5025GAS NCAFSN35502025-08-15
00754028835600Acufast The Earth Friendly Needle ANS35-6025GAS CAFSC35602025-08-15
00754028835617Acufast The Earth Friendly Needle - Non-Coated ANS35-6025GAS NCAFSN35602025-08-15
00754028840154Acufast The Earth Friendly Needle ANS40-1520GAS CAFSC40152025-08-15
00754028840307Acufast The Earth Friendly Needle ANS40-3020GAS CAFSC40302025-08-15
00754028840406Acufast The Earth Friendly Needle ANS40-4025GAS CAFSC40402025-08-15
00754028840505Acufast The Earth Friendly Needle ANS40-5025GAS CAFSC40502025-08-15
00754028840604Acufast The Earth Friendly Needle ANS40-6025GAS CAFSC40602025-08-15
00754028803005Fascia Buddy Silicone Cups - Lite - Set of 4 CP300CP3002025-08-15

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Primary DI, Brand, Company table
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