Duns Number:693307373
Device Description: Designed with both the patient and practitioner in mind, the new and advanced Pyonex™ Sing Designed with both the patient and practitioner in mind, the new and advanced Pyonex™ Singles continue SEIRIN's tradition of gentle, painless and stress free press needles. The patented plastic case and sheath allow the practitioner to insert the needle without touching the needle tip or the surface of the Micropore adhesive tape. This hypoallergenic latex-free adhesive allows the skin to breathe during treatment. No needle tip. The stimulation by pressing.
Catalog Number
-
Brand Name
SEIRIN PYONEX
Version/Model Number
Pyonex Zero Violet 0.20x0.3mm
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
-
Product Code
KNM
Product Code Name
Device, Pressure Applying
Public Device Record Key
56477144-aa44-4693-b8f9-22085e8785a6
Public Version Date
February 22, 2019
Public Version Number
3
DI Record Publish Date
May 24, 2018
Package DI Number
14547248423015
Quantity per Package
10
Contains DI Package
04547248423018
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX