Identity
- Trade Name
- ESTEEM FDA UDI
- Generic Name
- One-piece intestinal ostomy bag, closed-ended FDA UDI
- Device Name
- N/A FDA UDI
- Model / Reference
- 423689 FDA UDI
- Description
- N/A FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00768455204380 FDA UDI
- FDA Product Code
- EZQ FDA UDI
- GMDN Term
- One-piece intestinal ostomy bag, closed-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
No
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: One-piece intestinal ostomy bag, closed-ended
Esteem by Convatec, Purchasing Department — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- SenSura Mio Concave — Coloplast A/S · Class I
- Hollister — Hollister Incorporated · Class I
- SenSura Mio — Coloplast A/S · Class I
- SenSura Mio Convex — Coloplast A/S · Class I
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
- Convatec, Purchasing Department
Sources (1)
- FDA UDI 27a66df9-068e-4f1f-b703-85e6062ca5ac 34 fields · synced May 30, 2026