Duns Number:942011719
Device Description: The AcuTek Single Handle Bulk 10 Acupuncture Needle is well known for its smooth and painl The AcuTek Single Handle Bulk 10 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 Bulk Acupuncture Needle
Version/Model Number
A-1T 0.18 X 40
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
July 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
337e6754-1f0a-4309-951e-d5b6554e2254
Public Version Date
August 02, 2021
Public Version Number
4
DI Record Publish Date
September 23, 2016
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 |