Duns Number:653739474
Device Description: Hwato® Singles Acupuncture Needles. Copper handle needle with tube, one needle in one tube Hwato® Singles Acupuncture Needles. Copper handle needle with tube, one needle in one tube.
Catalog Number
Hs.22x13
Brand Name
Hwa-To Singles Acupuncture Needles
Version/Model Number
0.22x13
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
510f69c0-eb5e-45c1-929b-75764c61bbee
Public Version Date
December 31, 2018
Public Version Number
4
DI Record Publish Date
September 15, 2016
Package DI Number
36901452900021
Quantity per Package
100
Contains DI Package
16901452900027
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 |