Identity
- Trade Name
- ESTEEM+ FDA UDI
- Generic Name
- One-piece intestinal ostomy bag, open-ended FDA UDI
- Device Name
- Esteem®+ One-Piece Drainable Pre-Cut Pouch W/ Invisiclose®, Modified Stomahesive®, One-Sided Comfort Panel 12" Tranparent, 1 3/16" (30Mm) FDA UDI
- Model / Reference
- 416728 FDA UDI
- Description
- Esteem®+ One-Piece Drainable Pre-Cut Pouch W/ Invisiclose®, Modified Stomahesive®, One-Sided Comfort Panel 12" Tranparent, 1 3/16" (30Mm) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00768455111985 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
- 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, open-ended
A reliable and durable one-piece intestinal ostomy bag, designed for easy use and effective waste management. Learn more about its features, compliance, and benefits.
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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 3bbdb6b4-ab26-4848-b72f-08ff7ced2855 34 fields · synced Jul 25, 2026