Duns Number:545745192
Device Description: Painless Tai Chi™ needles, in blister packaging. Made of surgical stainless steel, Tai Chi Painless Tai Chi™ needles, in blister packaging. Made of surgical stainless steel, Tai Chi™ needles provide practitioners with a high quality needle at an affordable price. The flexible plastic 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 one acupuncture needle. Box of 1 needle, 0.45, 0.75 x 3 mm.
Catalog Number
BY2623
Brand Name
Tai Chi 7 Star Dermal Needle
Version/Model Number
BY2623
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
Product Code
MQX
Product Code Name
Needle, Acupuncture, Single Use
Public Device Record Key
b0b4043e-d451-46d6-8e0e-ae41b325cc6b
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 02, 2016
Package DI Number
36970514320657
Quantity per Package
10
Contains DI Package
16970514320653
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 |