Duns Number:080445043
Device Description: Alpha Acupuncture Needles, Sterile, Surgical Stainless steel acupuncture needle body, One Alpha Acupuncture Needles, Sterile, Surgical Stainless steel acupuncture needle body, One needle per tube, 100 needles per box.
Catalog Number
NAT1-3415
Brand Name
Alpha Acupuncture Needle
Version/Model Number
T1 Type 0.22 x 40 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)
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
37487ab6-5f6e-49b2-a32b-6685325b2304
Public Version Date
August 31, 2022
Public Version Number
5
DI Record Publish Date
March 15, 2017
Package DI Number
10818318022532
Quantity per Package
100
Contains DI Package
00818318022535
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 |