Duns Number:963324913
Device Description: MICROCATHETER MIC-021-150 REVERSE
Catalog Number
-
Brand Name
ReverseTM
Version/Model Number
MIC-021-150
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K122684
Product Code
DQY
Product Code Name
CATHETER, PERCUTANEOUS
Public Device Record Key
e11a4735-9583-4a02-a55e-e0f59bbdcd58
Public Version Date
December 22, 2021
Public Version Number
7
DI Record Publish Date
September 25, 2016
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. | 17 |