Identity
- Trade Name
- Isolation Device Mixed pack FDA UDI
- Generic Name
- Ostomy convexity insert FDA UDI
- Device Name
- Convenience kit containing 1 each: • REF 00860013000301 Wound Crown® • REF 00860013000325 Fistula Funnel® • REF 00860013000318 Isolator Strip® FDA UDI
- Model / Reference
- 00860013000394 FDA UDI
- Description
- Convenience kit containing 1 each: • REF 00860013000301 Wound Crown® • REF 00860013000325 Fistula Funnel® • REF 00860013000318 Isolator Strip® FDA UDI
Identifiers
- Catalog Number
- 00860013000394 FDA UDI
- Primary DI / UDI-DI
- 00860013000394 FDA UDI
- FDA Product Code
- EZS FDA UDI
- GMDN Term
- Ostomy convexity insert 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ostomy convexity insert
Isolation Device Mixed pack by Fistula Solution Corporation — 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
- Fistula Solution Corporation
Sources (1)
- FDA UDI 3d22716c-b979-42d7-b95c-8f3e3682a2f5 34 fields · synced Jun 8, 2026