Duns Number:094439676
Device Description: Sump Drain, Three Lumens, Silicone, Small Eye, With Suture Ring, With ClotStop®
Catalog Number
-
Brand Name
Axiom® Dual-Sump Atraum™ With ClotStop®
Version/Model Number
111196ATSR
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
727e7b65-d5fc-4c0b-b0a2-45ebdb765cb1
Public Version Date
October 24, 2018
Public Version Number
1
DI Record Publish Date
September 23, 2018
Package DI Number
M665111196ATSR3
Quantity per Package
10
Contains DI Package
M665111196ATSR1
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 |