Identity
- Trade Name
- SenSura Click FDA UDI
- Generic Name
- Intestinal ostomy base plate, flat FDA UDI
- Device Name
- SenSura Click / SenSura Click ostomy baseplate / SenSura Click Click ostomy baseplate. With belt ears. Coupling Size Diameter 60 mm, Coupling Size Diameter 2 3/8 in, Base Plate Precut Start Hole Size 40 mm, Base Plate Max Cut Size 55 mm, Baseplate Max Cut Size 2 1/8 in, Baseplate Precut Start Hole Size 1 9/16 in, Base Plate Type Flat. FDA UDI
- Model / Reference
- 10032 FDA UDI
- Description
- SenSura Click / SenSura Click ostomy baseplate / SenSura Click Click ostomy baseplate. With belt ears. Coupling Size Diameter 60 mm, Coupling Size Diameter 2 3/8 in, Base Plate Precut Start Hole Size 40 mm, Base Plate Max Cut Size 55 mm, Baseplate Max Cut Size 2 1/8 in, Baseplate Precut Start Hole Size 1 9/16 in, Base Plate Type Flat. FDA UDI
Identifiers
- Catalog Number
- 10032 FDA UDI
- Primary DI / UDI-DI
- 05708932377720 FDA UDI
- FDA Product Code
- EXB FDA UDI
- GMDN Term
- Intestinal ostomy base plate, flat FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.5900 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 60 Millimeter FDA UDI
Category: Intestinal ostomy base plate, flat
SenSura Click by Coloplast A/S — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Coloplast A/S
Sources (1)
- FDA UDI b4b6901a-aed3-4fe9-a978-a1e4ccabad11 36 fields · synced May 30, 2026