Duns Number:016898496
Device Description: Bardex® Malecot Drain Proportionate Head
Catalog Number
086040
Brand Name
Bardex® Malecot Model Drain
Version/Model Number
086040
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)
Yes
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
FEW
Product Code Name
Catheter, malecot
Public Device Record Key
050d4c9a-538e-4b0c-b3df-b94c69d8e57c
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
June 10, 2016
Package DI Number
10801741023962
Quantity per Package
6
Contains DI Package
00801741023965
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 472 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1994 |
| U | Unclassified | 10 |