Identity
- Trade Name
- ASCENT FDA UDI
- Generic Name
- Intravascular occluding balloon catheter, image-guided FDA UDI
- Device Name
- ASCENT balloon catheter Occlusion Balloon Catheter 4mm x 7mm 150 cm 3 cm 3 mm 2.9 F (0.98 mm) 0.0170 Inch (0.43 mm) Contents: 1 ASCENT Occlusion Balloon Catheter FDA UDI
- Model / Reference
- BRS000407-00 FDA UDI
- Description
- ASCENT balloon catheter Occlusion Balloon Catheter 4mm x 7mm 150 cm 3 cm 3 mm 2.9 F (0.98 mm) 0.0170 Inch (0.43 mm) Contents: 1 ASCENT Occlusion Balloon Catheter FDA UDI
Identifiers
- Catalog Number
- BRS00040700 FDA UDI
- Primary DI / UDI-DI
- 00878528001928 FDA UDI
- 510(k) Number
- K103780 FDA UDI
- FDA Product Code
- MJN FDA UDI
- GMDN Term
- Intravascular occluding balloon catheter, image-guided FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4450 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ascent by Medos International Sàrl — 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
- Medos International Sàrl
Sources (1)
- FDA UDI df78884f-ec4a-4c63-8c4e-fa601fc91d8b 38 fields · synced Jun 1, 2026