Duns Number:308951313
Device Description: M-Drain Centesis Catheter is used in percutaneous fluid aspirations and small volume drain M-Drain Centesis Catheter is used in percutaneous fluid aspirations and small volume drainage procedures.
Catalog Number
D40105010
Brand Name
M-Drain Centesis Catheter
Version/Model Number
D40105010
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"
Yes
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
GCB
Product Code Name
Needle, Catheter
Public Device Record Key
833f3f41-713d-443b-b18d-933cce35ccd0
Public Version Date
September 09, 2020
Public Version Number
2
DI Record Publish Date
August 05, 2019
Package DI Number
05711055001991
Quantity per Package
10
Contains DI Package
15711055001998
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Retail Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 90 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 152 |