Duns Number:080445043
Device Description: Plastic hammer with 12 replaceable heads; heads are sterilized and individually packed and Plastic hammer with 12 replaceable heads; heads are sterilized and individually packed and sealed; each head comes with seven 0.2mm diameter x 2mm long needles; flexible handle is 6" long.
Catalog Number
NP7-02
Brand Name
Alpha™ 7-Star Needle
Version/Model Number
7-Star Needle Set
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
588885c7-1b16-41ed-bdf6-88fb3e97af17
Public Version Date
August 31, 2022
Public Version Number
2
DI Record Publish Date
January 24, 2022
Package DI Number
10818318028077
Quantity per Package
100
Contains DI Package
00818318028070
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 |