Identity
- Trade Name
- ESTEEM+ FDA UDI
- Generic Name
- One-piece intestinal ostomy bag, closed-ended FDA UDI
- Device Name
- Esteem®+ Moldable One-Piece Closed Pouch, Filter, Modified Stomahesive, Two-Sided Window Comfort Panel 8" Opaque, (30/40Mm) FDA UDI
- Model / Reference
- 413510 FDA UDI
- Description
- Esteem®+ Moldable One-Piece Closed Pouch, Filter, Modified Stomahesive, Two-Sided Window Comfort Panel 8" Opaque, (30/40Mm) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00768455130061 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
Similar devices
Also classified as One-piece intestinal ostomy bag, closed-ended.
- SenSura Mio Concave — Coloplast A/S · Class I
- SenSura Mio Convex — Coloplast A/S · Class I
- Hollister — Hollister Incorporated · Class I
- SenSura Mio Convex — Coloplast A/S · Class I
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Convatec, Purchasing Department
Sources (1)
- FDA UDI 7f96e2b4-52b2-4545-933c-a2f3960101e7 34 fields · synced May 31, 2026