Duns Number:257053454
Device Description: Acufast needles are the world’s first consciously produced environmentally friendly acupun 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).
Catalog Number
AFSC2560
Brand Name
Acufast The Earth Friendly Needle
Version/Model Number
ANS25-6025GAS C
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MQX
Product Code Name
Needle, Acupuncture, Single Use
Public Device Record Key
2e0d0fca-51d9-4a59-b452-639640b02442
Public Version Date
December 04, 2020
Public Version Number
1
DI Record Publish Date
November 26, 2020
Package DI Number
10754028825608
Quantity per Package
10
Contains DI Package
00754028825601
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case