Identity
- Trade Name
- ESTEEM SYNERGY FDA UDI
- Generic Name
- Intestinal ostomy base plate, flat FDA UDI
- Device Name
- Esteem Synergy® Stomahesive® Skin Barrier With White Flexible Collar / Pre-Cut / 1 1/4" (32Mm) FDA UDI
- Model / Reference
- 405478 FDA UDI
- Description
- Esteem Synergy® Stomahesive® Skin Barrier With White Flexible Collar / Pre-Cut / 1 1/4" (32Mm) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00768455105106 FDA UDI
- FDA Product Code
- EXE FDA UDI
- GMDN Term
- Intestinal ostomy base plate, flat 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: Intestinal ostomy base plate, flat
Esteem Synergy by Convatec, Purchasing Department — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 2e5d2eeb-6998-4f63-8cf9-870fe2554ac0 34 fields · synced Jun 6, 2026