Identity
- Trade Name
- COBRA-OS® FDA UDI
- Generic Name
- Intravascular occluding balloon catheter, image-guided FDA UDI
- Device Name
- COBRA-OS Device EUDAMEDThe COBRA-OS® is intended for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage. FDA UDI
- Model / Reference
- F01P1 EUDAMEDFDA UDI
- Description
- The COBRA-OS® is intended for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage. FDA UDI
Identifiers
- Catalog Number
- F01P1 FDA UDI
- Primary DI / UDI-DI
- 10628678061054 EUDAMEDFDA UDI
- Basic UDI-DI
- 628678061001HJ EUDAMED
- 510(k) Number
- K201652 FDA UDI
- FDA Product Code
- MJN FDA UDI
- EMDN Code
- C019009 AORTIC OCCLUSION SYSTEMS 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
- Spain 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 64.9 Centimeter FDA UDIBalloon Catheter Tip Length — 6.4 Centimeter FDA UDIOuter Diameter — 1.35 Millimeter FDA UDIBalloon Diameter — 25 Millimeter FDA UDICatheter Working Length — 55 Centimeter FDA UDI
COBRA-OS Device by Front Line Medical Technologies Inc. — Class III — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 628678061001HJ | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Front Line Medical Technologies Inc.
- EUDAMED SRN
- CA-MF-000035504
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (2)
- EUDAMED 624f2745-78e4-421d-acd8-06daf081409a 61 fields · synced Jun 19, 2026
- FDA UDI ad938e78-d7f7-4e27-9355-d1ccea75300f 36 fields · synced May 30, 2026