Identity
- Trade Name
- Coloplast FDA UDI
- Generic Name
- Colostomy rod FDA UDI
- Model / Reference
- 12814 FDA UDI
Identifiers
- Catalog Number
- 12814 FDA UDI
- Primary DI / UDI-DI
- 05708932752558 FDA UDI
- FDA Product Code
- EZP FDA UDI
- GMDN Term
- Colostomy rod FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4270 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Category: Colostomy rod
Coloplast by Coloplast A/S — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Colostomy rod.
- SUR-FIT LOOP OSTOMY ROD 65MM — CONVATEC, PURCHASING DEPARTMENT · Class II
- Barbell Loop Ostomy Device — TOOLS FOR SURGERY, LLC · Class II
- Bioseal Inc. — BIOSEAL · Class I
- VISI-FLOW STOMA CONE — CONVATEC, PURCHASING DEPARTMENT · Class II
- Barbell Loop Ostomy Device — TOOLS FOR SURGERY, LLC · Class II
- SUR-FIT LOOP OSTOMY ROD 90MM — CONVATEC, PURCHASING DEPARTMENT · Class II
- Bioseal Inc. — BIOSEAL · Class I
- Barbell Loop Ostomy Device — TOOLS FOR SURGERY, LLC · Class II
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 6b59cde1-2ffe-432e-ad4f-396a4a306dd8 35 fields · synced May 30, 2026