Identity
- Trade Name
- iCAST FDA UDI
- Generic Name
- Polymer-metal tracheal/bronchial stent FDA UDI
- Device Name
- iCAST COVERED STENT, 6MMX59MMX80CM FDA UDI
- Model / Reference
- 85403 FDA UDI
- Description
- iCAST COVERED STENT, 6MMX59MMX80CM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00650862854039 FDA UDI
- 510(k) Number
- K050814 FDA UDI
- FDA Product Code
- JCT FDA UDI
- GMDN Term
- Polymer-metal tracheal/bronchial stent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3720 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
iCAST by Atrium Medical Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Atrium Medical Corp.
Sources (1)
- FDA UDI a2e1a964-1ba0-4e6d-90f8-f329d32f139f 35 fields · synced Jun 8, 2026