Duns Number:693307373
Device Description: An essential part of cosmetic acupuncture and other treatment modalities, Spinex™ intrader An essential part of cosmetic acupuncture and other treatment modalities, Spinex™ intradermal needles (hinai-shin) provide you with a high quality option for specialized acupuncture treatments. These individually packaged, disposable needles are made entirely of surgical stainless steel. The heat-sealed blister package ensures sterility, while the perforated tear-off strip makes them easy to use. With a ring handle measuring 1.5mm in diameter, Spinex™ is available in 3 different lengths. To use, simply open the blister package, grip the head of the needle with tweezers, remove and insert. One sterile needle per blister package. Box of 100 needles.
Catalog Number
-
Brand Name
SEIRIN SPINEX NEEDLE
Version/Model Number
NS No.01(0.14)x5mm
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
077b495a-67d8-4309-ab0b-ceed1054dabb
Public Version Date
June 04, 2018
Public Version Number
3
DI Record Publish Date
September 12, 2016
Package DI Number
14547248500099
Quantity per Package
10
Contains DI Package
04547248500092
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX