Duns Number:545745192
Device Description: Painless Tai Chi™ needles, in economical bulk packaging. Made of surgical stainless steel, Painless Tai Chi™ needles, in economical bulk packaging. Made of surgical stainless steel, Tai Chi™ Power 80 needles provide practitioners with a high quality needle at an affordable price. The flexible "spring" style metal handle provides superior grip for the practitioner, while the advanced manufacturing process provides a painless experience for the patient. Each easy-open plastic package contains eight sterile acupuncture needles with one insertion tube. Box of 80 needles, 0.25 x 30 mm.
Catalog Number
AY71017
Brand Name
Tai Chi™ Power 80
Version/Model Number
AY7107
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
f0c7cb9a-2be7-418a-baf7-4c542b119ec0
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 22, 2016
Package DI Number
36970514320077
Quantity per Package
10
Contains DI Package
16970514320073
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 |