Duns Number:545745192
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, 0.22 x13mm.
Catalog Number
AY8603
Brand Name
Gold Tai Chi™
Version/Model Number
AY8603
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
K023787,K023787,K023787
Product Code
MQX
Product Code Name
Needle, Acupuncture, Single Use
Public Device Record Key
3dabe461-b87a-4a0c-b3a5-ea161a4c811c
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 26, 2016
Package DI Number
36970514320466
Quantity per Package
10
Contains DI Package
16970514320462
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 2 |