Duns Number:654613546
Device Description: Smooth and sharp for painless, AcuZone disposable sterile Press Tack needles are made of h Smooth and sharp for painless, AcuZone disposable sterile Press Tack needles are made of high quality surgical stainless steel. Steriliized with Ethylene Oxide and each individually sealed. Box of 100 needles. 0.20mm x 2.0mm.
Catalog Number
PN2020
Brand Name
AcuZone
Version/Model Number
PN2020
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
6f5d3963-5bbb-4060-a57c-3747563cb38b
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 02, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-