Identity
- Trade Name
- Merocel FDA UDI
- Generic Name
- Nasal haemostatic balloon FDA UDI
- Device Name
- CATHETER 400470 EPISTAT II NASAL FDA UDI
- Model / Reference
- 400470 FDA UDI
- Description
- CATHETER 400470 EPISTAT II NASAL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20681490105433 FDA UDI
- FDA Product Code
- EMX FDA UDI
- GMDN Term
- Nasal haemostatic balloon FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4100 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Merocel by Medtronic Xomed, Inc. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Medtronic Xomed, Inc.
Sources (1)
- FDA UDI f1a0a81c-d303-42e5-91c4-a1cf784be22a 35 fields · synced Jun 1, 2026