Duns Number:305524696
Device Description: Coloplast Fistula and Wound Management System / Coloplast / Coloplast Fistula and wound Coloplast Fistula and Wound Management System / Coloplast / Coloplast Fistula and wound management system / Coloplast Free. without filter. 1 Fistula and Wound Manager Midi. 1 Fistula Flexible Lid Midi without filter. 1 Tracing guide. 1 Transparent cover sheet. 1 Fistula Drain Port. 1 Clamp. 1 Pump per retail box. Midi. Fistula and Wound Manager Size Midi.
Catalog Number
14060
Brand Name
Coloplast
Version/Model Number
14060
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
FON
Product Code Name
BAG, DRAINAGE, WITH ADHESIVE, OSTOMY
Public Device Record Key
596d8010-ccc5-4bee-b6a3-a9ec0a63c78f
Public Version Date
March 21, 2022
Public Version Number
1
DI Record Publish Date
March 11, 2022
Package DI Number
00762123049464
Quantity per Package
2
Contains DI Package
00762123049457
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 46 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 899 |
| 3 | A medical device with high risk that requires premarket approval | 72 |
| U | Unclassified | 7 |