Duns Number:080493003
Device Description: Featuring a traditional “spring” style handle that comes in blister packs of 10 needles an Featuring a traditional “spring” style handle that comes in blister packs of 10 needles and one guide tube, the Balance 1KS is an achievement in combining the highest quality with unprecedented value.
Catalog Number
-
Brand Name
Balance 1KS Acupuncture Needle
Version/Model Number
Balance 1KS-Type 1815
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
8749ae9f-ea45-4db0-820b-9eb23487c80b
Public Version Date
February 11, 2019
Public Version Number
1
DI Record Publish Date
January 09, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-