Duns Number:693307373
Device Description: The J-15 is perfect for facial, auricular, hand acupuncture, or wherever shallow needling The J-15 is perfect for facial, auricular, hand acupuncture, or wherever shallow needling is performed. Available in the thinnest gauges you can find (03, 02, 01, and 1), this 15 mm needle comes with rounded guide tubes for accurate, gentle, painless and stress-free acupuncture. The J-15 also features ProPak™ technology, which allows you to open one or more blister packs quickly and easily. One surgical stainless steel needle per blister package. Features lightweight, color coded, 2.0 x 20 mm easy release comfort grip plastic handle with Light Touch Insertion. Sterile, disposable. Box of 100 needles.
Catalog Number
-
Brand Name
SEIRIN ACUPUNCTURE NEEDLE
Version/Model Number
J15 No.02(0.12)x15mm
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
e92e0743-257f-40d0-84a4-c879d08f9d0f
Public Version Date
June 04, 2018
Public Version Number
3
DI Record Publish Date
December 19, 2016
Package DI Number
14547248131040
Quantity per Package
10
Contains DI Package
04547248131043
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX