Duns Number:061228290
Device Description: High quality, painless, sterile, gold plated, surgical stainless steel Chinese acupuncture High quality, painless, sterile, gold plated, surgical stainless steel Chinese acupuncture needles with spiral wound gold plated copper handle. One needle with one insertion tube per sterile, individually sealed blister package. Box of 100. Size:36Gauge x 25mm (1.0")
Catalog Number
G3610
Brand Name
HBW SILVERSTAR 24K Gold Plated Acupuncture Needles
Version/Model Number
G Type No.36G x 25mm(1.0")
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
7910494e-a658-494a-88e7-e6b68afade61
Public Version Date
January 18, 2022
Public Version Number
1
DI Record Publish Date
January 10, 2022
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 |