Duns Number:079105071
Device Description: 14F x 45cm Total Abscession General Drainage Catheter (Locking Pigtail)
Catalog Number
-
Brand Name
Total Abscession
Version/Model Number
14000830
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
89f8cf86-ab64-4993-b150-2854824e9c14
Public Version Date
March 08, 2022
Public Version Number
4
DI Record Publish Date
September 16, 2015
Package DI Number
H787140008305
Quantity per Package
5
Contains DI Package
H787140008300
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 203 |