Identity
- Trade Name
- AVANTGARDE FDA UDI
- Generic Name
- Faecal collection toilet sheet FDA UDI
- Device Name
- Fecal Collection Bag FDA UDI
- Model / Reference
- AVG200 FDA UDI
- Description
- Fecal Collection Bag FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060182172112 FDA UDI
- 510(k) Number
- K193325 FDA UDI
- FDA Product Code
- KNT FDA UDI
- GMDN Term
- Faecal collection toilet sheet FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5980 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Faecal collection toilet sheet
Avantgarde by Prosys International, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K193325 also covers:
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 II | Pending data |
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Manufacturer
- Manufacturer
- Prosys International, Ltd.
Sources (1)
- FDA UDI 222aa0de-93dd-4c7c-ae59-1351d36bbb75 34 fields · synced May 30, 2026