DEVICE: Fistula Funnel (00860013000325)
Device Identifier (DI) Information
Fistula Funnel
00860013000325
In Commercial Distribution
00860013000325
Fistula Solution Corporation
00860013000325
In Commercial Distribution
00860013000325
Fistula Solution Corporation
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
47658 | Ostomy convexity insert |
A device designed to help improve contact between the flange of a two-piece or multiple-piece ostomy appliance and the peristomal skin of a flush stoma or more typically a recessed stoma (a stoma with an adjacent depression, scar, crease, or other condition) for which additional barrier-to-skin contact is desirable. The device is placed between the ostomy appliance flange and the stomal skin typically to fill gaps between the two by providing convexity (an outward bulge), reducing the likelihood of leakage. After application, this device cannot be reused.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EZS | Appliance, Colostomy, Disposable |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
54691bee-55df-4a4a-a66a-d45a81be7d9f
August 29, 2022
1
August 20, 2022
August 29, 2022
1
August 20, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10860013000322 | 10 | 00860013000325 | In Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined