Duns Number:801197380
Device Description: AA acupuncture needles are made from high quality surgical stainless steel with spiral-wou AA acupuncture needles are made from high quality surgical stainless steel with spiral-wound handles. These single-use needles are sharp and precise for a smooth insertion. High caliber, yet affordable, AA needles are an amazing alternative to more expensive brands. This is a bulk pack offering a more economical price. 10 needles with one (insertion) guide tube per sterile, individually sealed blister package. Box of 1000 needles. 0.25mm x 50mm (32# x 2.0").
Catalog Number
-
Brand Name
AA Acupuncture Needles
Version/Model Number
A2A-32-200
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
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
87abea38-62ad-426b-8013-900568f92c38
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 15, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |