Duns Number:528182887
Device Description: Tungsten Micro Needle 5cm 45°Angle
Catalog Number
-
Brand Name
WickiMed
Version/Model Number
138504
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
5b620f58-065f-4f31-bb24-da463562a284
Public Version Date
January 24, 2022
Public Version Number
1
DI Record Publish Date
January 14, 2022
Package DI Number
26970739450019
Quantity per Package
40
Contains DI Package
06970739450015
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 5 |