Duns Number:942011719
Device Description: The AcuTek Copper Handle Bulk Acupuncture Needle is well known for its smooth and painless The AcuTek Copper Handle Bulk 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 Copper Bulk Acupuncture Needle
Version/Model Number
A-2C 0.20 X 25mm
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
May 30, 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
K974122,K974122
Product Code
MQX
Product Code Name
Needle, Acupuncture, Single Use
Public Device Record Key
53085eda-0104-4008-8ca4-19b8465b552f
Public Version Date
July 30, 2021
Public Version Number
5
DI Record Publish Date
May 31, 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 |
| U | Unclassified | 3 |