Duns Number:094439676
Device Description: Closed Wound Facial Drains (Two), Flat, Silicone, With Bifurcated Connector, With ClotStop Closed Wound Facial Drains (Two), Flat, Silicone, With Bifurcated Connector, With ClotStop®
Catalog Number
-
Brand Name
Axiom® CWV Facial Atraum™ With ClotStop®
Version/Model Number
412AT
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K883887,K883887,K883887
Product Code
GBS
Product Code Name
Catheter, Ventricular, General & Plastic Surgery
Public Device Record Key
08294b9d-aaeb-4239-a0da-05c94bab8b07
Public Version Date
March 08, 2022
Public Version Number
2
DI Record Publish Date
September 23, 2018
Package DI Number
M665412AT3
Quantity per Package
6
Contains DI Package
M665412AT1
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 187 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 131 |