Identity
- Trade Name
- Bridge Occlusion Balloon EUDAMEDFDA UDI
- Generic Name
- Intravascular occluding balloon catheter, image-guided FDA UDI
- Device Name
- Bridge Occlusion Balloon EUDAMED
- Model / Reference
- 590-001 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 590-001 FDA UDI
- Primary DI / UDI-DI
- 00813132024840 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00813132024840 EUDAMED
- FDA Product Code
- MJN FDA UDI
- EMDN Code
- C0104020103 VASCULAR OCCLUSION CATHETERS EUDAMED
- GMDN Term
- Intravascular occluding balloon catheter, image-guided FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 870.4450 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Dimensions & Sizes
- Size
- Length — 90 Centimeter FDA UDI
Bridge Occlusion Balloon by Spectranetics Corporation — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00813132024840 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Spectranetics Corporation
- EUDAMED SRN
- US-MF-000020669
- Authorised Representative
- Spectranetics International B.V. NL-AR-000001484
Sources (2)
- EUDAMED bae2ce49-5fa7-4cd4-a257-d7d34f5ae96e 61 fields · synced Jul 22, 2026
- FDA UDI 37171913-f932-4619-a22b-12c532de0c6b 36 fields · synced May 30, 2026