Identity
- Trade Name
- Coloplast FDA UDI
- Generic Name
- Rectal/colonic irrigation nozzle, reusable FDA UDI
- Device Name
- Coloplast Irrigation, Cone FDA UDI
- Model / Reference
- 01110 FDA UDI
- Description
- Coloplast Irrigation, Cone FDA UDI
Identifiers
- Catalog Number
- 01110 FDA UDI
- Primary DI / UDI-DI
- 05708932619813 FDA UDI
- FDA Product Code
- EXD FDA UDI
- GMDN Term
- Rectal/colonic irrigation nozzle, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5895 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Rectal/colonic irrigation nozzle, reusable
Coloplast by Coloplast A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rectal/colonic irrigation nozzle, reusable.
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 II | Pending data |
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Manufacturer
- Manufacturer
- Coloplast A/S
Sources (1)
- FDA UDI 36e2af52-4040-4e6f-b1e5-c030ac7d5c05 36 fields · synced May 31, 2026