Identity
- Trade Name
- ESTEEM SYNERGY FDA UDI
- Generic Name
- One-piece intestinal ostomy bag, open-ended FDA UDI
- Device Name
- Esteem Synergy Professional Kit, Non-Sterile (Extra Large) Kit Contains, 5 each 14 in Transparent, Straight Drainable Pouches, Extra Large FDA UDI
- Model / Reference
- 409275 FDA UDI
- Description
- Esteem Synergy Professional Kit, Non-Sterile (Extra Large) Kit Contains, 5 each 14 in Transparent, Straight Drainable Pouches, Extra Large FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00768455105267 FDA UDI
- FDA Product Code
- FON 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
- Not 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Esteem Synergy by Convatec, Purchasing Department — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Convatec, Purchasing Department
Sources (1)
- FDA UDI b91c5cf5-3aba-4065-a12c-757fc154c8d5 35 fields · synced May 31, 2026