Duns Number:942011719
Device Description: Kingli Acupuncture Needle is well known for its long tradition, quality and value. It is o Kingli Acupuncture Needle is well known for its long tradition, quality and value. It is one of the best selling acupuncture needles in the U.S.
Catalog Number
-
Brand Name
Kingli Single Acupuncture Needle
Version/Model Number
A-1K 0.40 X 25
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
d2d1fa4f-6c6e-45b0-a4c2-8dcdd2f24abd
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 |