Duns Number:653739474
Device Description: Hwato® Five Acupuncture Needles. Bulk-5 Packs. Silver plated copper handle needle with gu Hwato® Five Acupuncture Needles. Bulk-5 Packs. Silver plated copper handle needle with guide tube, 200 needles with 24 tubes.
Catalog Number
Hf.22x40
Brand Name
Hwa-To Five Acupuncture Needles
Version/Model Number
0.22x40
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
7f54b5d4-b855-4260-a7df-ba6c1a92fb6c
Public Version Date
December 31, 2018
Public Version Number
4
DI Record Publish Date
September 15, 2016
Package DI Number
36901452940102
Quantity per Package
50
Contains DI Package
16901452940108
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 |