Duns Number:344007369
Device Description: The Fistula Brush can be used for probing of the fistula tract and for debridement before The Fistula Brush can be used for probing of the fistula tract and for debridement before using the OTSC Proctology • it is used to clean the fistula tract and remove granulation tissue • supports obliteration of fistula tract
Catalog Number
200.62
Brand Name
Fistula Brush
Version/Model Number
Proctology
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
MDM
Product Code Name
Instrument, Manual, Surgical, General Use
Public Device Record Key
8d52cd84-a475-4682-896a-78dede861832
Public Version Date
October 31, 2019
Public Version Number
4
DI Record Publish Date
September 16, 2016
Package DI Number
4260206310280
Quantity per Package
5
Contains DI Package
04260206310631
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Folding box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 61 |