Duns Number:942011719
Device Description: The AcuTek Spring Handle Tabless Acupuncture Needle is well known for its smooth and painl The AcuTek Spring Handle Tabless Acupuncture Needle is well known for its smooth and painless insertion. It is one of the best acupuncture needles in the U.S.
Catalog Number
-
Brand Name
AcuTek Spring Handle Tabless Acupuncture Needle
Version/Model Number
A-3 0.20 x 15 mm
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
March 31, 2023
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
f871c1d2-0a63-47bd-be81-5b70603e0b13
Public Version Date
August 02, 2021
Public Version Number
3
DI Record Publish Date
February 25, 2019
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 |
| U | Unclassified | 3 |