Duns Number:653739474
Device Description: HWATO Yuezhen - ACA COMFORT NEEDLE, sterile, disposable, and surgical stainless steel Acup HWATO Yuezhen - ACA COMFORT NEEDLE, sterile, disposable, and surgical stainless steel Acupuncture Needles with spring style stainless steel handle. Bulk pack with 10 needles and one insertion tube per sterile, individually sealed package. Box of 1000 needles.
Catalog Number
-
Brand Name
HWATO Yuezhen - ACA COMFORT NEEDLE
Version/Model Number
0.25X13
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
36e02420-bad5-4f4f-8e73-9e1ec2e424ad
Public Version Date
August 23, 2019
Public Version Number
1
DI Record Publish Date
August 15, 2019
Package DI Number
36901452648176
Quantity per Package
20
Contains DI Package
16901452648172
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 |