Duns Number:303655286
Device Description: The Comfort Drain is a flexible, silicone, elastic drain with knotless closure that facili The Comfort Drain is a flexible, silicone, elastic drain with knotless closure that facilitates drainage of perianal fistulas.
Catalog Number
CDS2001
Brand Name
Comfort Drain
Version/Model Number
CDS2001
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
-
Product Code
GBN
Product Code Name
Catheter, Pediatric, General & Plastic Surgery
Public Device Record Key
5fd7cc60-c6e2-461b-96b5-36ca02fbd663
Public Version Date
March 08, 2022
Public Version Number
2
DI Record Publish Date
November 28, 2018
Package DI Number
EAMICDS20011
Quantity per Package
10
Contains DI Package
EAMICDS20010
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 47 |