Duns Number:338664915
Device Description: A sterile and single-use silicone device characterized by a drainage groove section and a A sterile and single-use silicone device characterized by a drainage groove section and a round section portion.
Catalog Number
24904
Brand Name
Smart Drain Round Fluted Drain w/bendable trocar Fr 19
Version/Model Number
24904
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
-
Product Code
GBX
Product Code Name
Catheter, Irrigation
Public Device Record Key
07a6a848-1d19-4a44-9d4c-99860a083499
Public Version Date
March 08, 2022
Public Version Number
2
DI Record Publish Date
May 07, 2021
Package DI Number
18034139296583
Quantity per Package
10
Contains DI Package
08034139296586
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 105 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |