Duns Number:545745192
Device Description: Sterile, disposable, surgical stainless steel Chinese style acupuncture needles with spira Sterile, disposable, surgical stainless steel Chinese style acupuncture needles with spiral wound silver plated copper handle. One needle with one insertion tube per sterile, individually sealed blister package. Box of 100, 0.30 x 75mm.
Catalog Number
AY8124
Brand Name
Tai Chi™ Single
Version/Model Number
AY8124
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
b9739db4-bb1a-4661-87ce-35cdc8f47bf6
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 26, 2016
Package DI Number
36970514320282
Quantity per Package
10
Contains DI Package
16970514320288
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 |