Bag, Drainage, With Adhesive, Ostomy

Device Code: 1919

Product Code(s): FON

Device Classification Information

Device Type ID1919
Device NameBag, Drainage, With Adhesive, Ostomy
Regulation DescriptionOstomy Pouch And Accessories.
Regulation Medical SpecialtyGastroenterology/Urology
Review PanelGastroenterology/Urology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD)
Gastroenterology Devices Branch (GEDB)
Submission Type510(K) Exempt
CFR Regulation Number876.5900 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeFON
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1919
DeviceBag, Drainage, With Adhesive, Ostomy
Product CodeFON
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionOstomy Pouch And Accessories.
CFR Regulation Number876.5900 [🔎]
Device Problems
Failure To Adhere Or Bond
3
Adverse Event Without Identified Device Or Use Problem
3
Device Handling Problem
2
Device Contamination With Chemical Or Other Material
1
Use Of Device Problem
1
Difficult To Remove
1
Total Device Problems 11
TPLC Last Update: 2019-04-02 20:02:00

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