Duns Number:061228290
Device Description: Acupuncture needle with a flat needlepoint, stainless steel with the lightweight aluminum Acupuncture needle with a flat needlepoint, stainless steel with the lightweight aluminum handle, one needle with one guide tube. the size is the size 0.40 x 75mm, 100pcs per box.
Catalog Number
23454
Brand Name
WABBO PI ZHEN
Version/Model Number
0.40 x 75 mm
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 12, 2021
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)
Yes
FDA Premarket Submission
-
Product Code
MQX
Product Code Name
Needle, Acupuncture, Single Use
Public Device Record Key
4ea4dc9a-48be-400b-a0a9-0826aca9dc1f
Public Version Date
April 20, 2021
Public Version Number
1
DI Record Publish Date
April 12, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 51 |