Duns Number:653739474
Device Description: Hua Xia™ Basic Acupuncture Needles. Copper handle needle without tube.
Catalog Number
Xb.30x25
Brand Name
Hua-Xia Basic Acupuncture Needles
Version/Model Number
0.30x25
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
-
Product Code
MQX
Product Code Name
Needle, Acupuncture, Single Use
Public Device Record Key
d711955d-6450-41c2-bf9b-83272323fb24
Public Version Date
December 31, 2018
Public Version Number
4
DI Record Publish Date
September 15, 2016
Package DI Number
36901452970079
Quantity per Package
100
Contains DI Package
16901452970075
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 |