Duns Number:080445043
Device Description: Spring style metal handle, 10 needles with 1 guide tube. 1,000 needles per box.
Catalog Number
NAN1-2820
Brand Name
Alpha™ Acupuncture Needles
Version/Model Number
N1 Type 0.35 x 50 mm
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)
-
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
7395e3aa-a4a3-4d83-ab46-593e7ca5d866
Public Version Date
September 22, 2022
Public Version Number
3
DI Record Publish Date
January 24, 2022
Package DI Number
10818318024840
Quantity per Package
20
Contains DI Package
00818318024843
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. | 4 |