Duns Number:061228290
Device Description: Sterile, disposable, High quality surgical stainless steel Chinese style acupuncture needl Sterile, disposable, High quality surgical stainless steel Chinese style acupuncture needles with spiral wound silver plated copper handle. smoothly and painless. 1 needle per guide tube with a color coded tab to hold the needle in place. Box of 100. Size: 44 Gauge x 13mm (0.5")
Catalog Number
N4405
Brand Name
HBW SILVERSTAR
Version/Model Number
N Type No. 44G x 15mm(0.5")
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)
Yes
FDA Premarket Submission
-
Product Code
MQX
Product Code Name
Needle, Acupuncture, Single Use
Public Device Record Key
d6b5c81c-a13b-4874-bad0-c31f3577b421
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 06, 2017
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 |