Identity
- Trade Name
- Alterna FDA UDI
- Generic Name
- One-piece intestinal ostomy bag, open-ended FDA UDI
- Model / Reference
- 15870 FDA UDI
Identifiers
- Catalog Number
- 15870 FDA UDI
- Primary DI / UDI-DI
- 00762123046302 FDA UDI
- FDA Product Code
- EXB FDA UDI
- GMDN Term
- One-piece intestinal ostomy bag, open-ended 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
Category: One-piece intestinal ostomy bag, open-ended
Alterna by Coloplast A/S — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as One-piece intestinal ostomy bag, open-ended.
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- Premier — Hollister Incorporated · Class I
- Premier — Hollister Incorporated · Class I
- Premier — Hollister Incorporated · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Coloplast A/S
Sources (2)
- FDA UDI d58c7f6a-baad-466d-8807-42e22b5b0569 35 fields · synced Oct 7, 2026
- EUDAMED 1 fields · synced Jun 1, 2026