Duns Number:801197380
Device Description: Produced with high-quality surgical stainless steel, AcuSTAR acupuncture needles are desig Produced with high-quality surgical stainless steel, AcuSTAR acupuncture needles are designed for smooth and painless insertion. These Korean-type needles are sterile, disposable, single-use needles with spiral-wound handles. Ten needles with one (insertion) guide tube per sterile, individually sealed blister package. Box of 1000 needles. 0.30mm x 30mm (30# x 1.0").
Catalog Number
-
Brand Name
AcuSTAR Acupuncture Needles
Version/Model Number
A2S-30-100
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
3e6e0548-27de-4248-80d8-c449733c20d8
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 10, 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 |