Duns Number:654613546
Device Description: Smooth and sharp for painless, SHENMEN disposable sterile acupuncture needles are made of Smooth and sharp for painless, SHENMEN disposable sterile acupuncture needles are made of high quality surgical stainless steel and the handle is without loop. Sterilized with Ethylene Oxide. Each needle is individually sealed with guide tube. 0.25mm x 40mm (32# x 1.5").
Catalog Number
SM132150
Brand Name
SHENMEN
Version/Model Number
SM132150
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
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
9815f3e5-5f3e-4ce8-ac54-924f4877d51a
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 02, 2018
Package DI Number
B491SM1321503
Quantity per Package
100
Contains DI Package
B491SM1321501
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-