Duns Number:080445043
Device Description: Surgical stainless steel, Plastic handle, High-tensile surgical stainless steel body, Comf Surgical stainless steel, Plastic handle, High-tensile surgical stainless steel body, Comfortable needle for patients.
Catalog Number
NAY1-4820
Brand Name
Alpha™ Acupuncture Needles
Version/Model Number
Y1 Type 0.48 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
7393f370-9738-4590-b780-66d578c86f2f
Public Version Date
August 31, 2022
Public Version Number
2
DI Record Publish Date
January 24, 2022
Package DI Number
10818318025328
Quantity per Package
50
Contains DI Package
00818318025321
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 |