Identity
- Trade Name
- MO.MA ULTRA FDA UDI
- Generic Name
- Carotid artery embolic protection system FDA UDI
- Device Name
- CATH MUS0130069X6 CPD ULTRA US 9F UL950 FDA UDI
- Model / Reference
- MUS0130069X6 FDA UDI
- Description
- CATH MUS0130069X6 CPD ULTRA US 9F UL950 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08033477090719 FDA UDI
- 510(k) Number
- K092177 FDA UDI
- FDA Product Code
- NTE FDA UDI
- GMDN Term
- Carotid artery embolic protection system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1250 FDA UDI
- Commercial Distribution
- 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Carotid artery embolic protection system
Mo.ma Ultra by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K092177 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
- Medtronic, Inc.
Sources (1)
- FDA UDI 10a6da1a-20e5-4955-808d-cd2d0f07a8ae 37 fields · synced May 30, 2026