Duns Number:654613546
Device Description: Smooth and sharp for painless, AcuZone disposable sterile acupuncture needles are made of Smooth and sharp for painless, AcuZone disposable sterile acupuncture needles are made of high quality surgical stainless steel and the handle is without loop. Steriliized with Ethylene Oxide, each needle is individually sealed with a guide tube. Box of 100 needles. 0.25mm x 75mm (32# x 3.0").
Catalog Number
AZ 1-2575
Brand Name
AcuZone
Version/Model Number
AZ 1-2575
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
de28d066-7a3f-4170-a209-84216da2743d
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
December 21, 2017
Package DI Number
B491AZ125753
Quantity per Package
100
Contains DI Package
B491AZ125751
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-