Duns Number:079456139
Device Description: Micro Plug Set - 3mm
Catalog Number
90000
Brand Name
Micro Plug Set
Version/Model Number
90000
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K182944
Product Code
KRD
Product Code Name
Device, Vascular, For Promoting Embolization
Public Device Record Key
7ab1da43-643b-476b-9d69-e4b289cf4a1e
Public Version Date
February 05, 2021
Public Version Number
3
DI Record Publish Date
April 25, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 4 |