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. With SEIRIN's consistently smooth insertion, the result is a pleasant and painless experience for your patient.
Catalog Number
-
Brand Name
SEIRIN PYONEX
Version/Model Number
Pyonex Green 0.17x0.9mm
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
MQX
Product Code Name
Needle, Acupuncture, Single Use
Public Device Record Key
bf65f9b2-d01b-435a-a657-163d1e75813c
Public Version Date
June 04, 2018
Public Version Number
3
DI Record Publish Date
August 22, 2017
Package DI Number
14547248420038
Quantity per Package
10
Contains DI Package
04547248420031
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX