Duns Number:693307373
Device Description: ELIPEAS is perfect for facial, auricular acupuncture especially treating the body parts wh ELIPEAS is perfect for facial, auricular acupuncture especially treating the body parts where needles inserted superficially. Stabled needle retention with less-weighed-handle. ELIPEAS is available only in a length of 7mm and does not have guide tubes, which makes it ideal for freehand techniques. 4 needles per plastic case. This plastic case not only preserves the needle but also converts into both standing and portable functional dispenser by folding it. The color-coded 18 mm plastic handle gives the practitioner a secure grip. Box of 100 sterile, disposable needles.
Catalog Number
-
Brand Name
SEIRIN ACUPUNCTURE NEEDLE
Version/Model Number
ELIPEAS No.02(0.12)x7mm
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
ac0112e3-e204-4d7b-a39a-4c82015a3938
Public Version Date
September 02, 2021
Public Version Number
1
DI Record Publish Date
August 25, 2021
Package DI Number
14547248140042
Quantity per Package
10
Contains DI Package
04547248140045
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX