Duns Number:080493003
Device Description: Featuring a traditional “Spiral & Loop” style handle that comes one guide tube per needle, Featuring a traditional “Spiral & Loop” style handle that comes one guide tube per needle, the Balance SL-Type is an achievement in combining the highest quality with unprecedented value.
Catalog Number
-
Brand Name
Balance SL-Type Acupuncture Needle
Version/Model Number
Balance SL-Type 1830
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K150903,K150903
Product Code
MQX
Product Code Name
Needle, acupuncture, single use
Public Device Record Key
89d8e0aa-2d0e-49f8-a6bf-4ecffc055d6e
Public Version Date
February 11, 2019
Public Version Number
1
DI Record Publish Date
January 10, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-