Duns Number:653739474
Device Description: HWATO Yuezhen acupuncture needles, sterile, disposable, and surgical stainless steel Acupu HWATO Yuezhen acupuncture needles, sterile, disposable, and surgical stainless steel Acupuncture Needles with spring style stainless steel handle. One needle with one insertion tube per sterile, individually sealed blister package. Box of 100 needles.
Catalog Number
-
Brand Name
HWATO Yuezhen
Version/Model Number
0.22 x 40
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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,K974122
Product Code
MQX
Product Code Name
Needle, Acupuncture, Single Use
Public Device Record Key
dee60b03-f276-4c53-9bb0-20bade594bb1
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 26, 2017
Package DI Number
36901452600563
Quantity per Package
100
Contains DI Package
16901452600569
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |