Identity
- Trade Name
- Fusion® Titan™ EUDAMEDFusion Titan FDA UDI
- Generic Name
- Gastrointestinal/biliary dilation balloon catheter, non-medicated FDA UDI
- Device Name
- Fusion® Titan™ Biliary Dilation Balloon EUDAMEDFusion Titan Biliary Dilation Balloon 3.2mm FDA UDI
- Model / Reference
- FS-BDB-8X4 EUDAMEDG49221 FDA UDI
- Description
- Fusion Titan Biliary Dilation Balloon 3.2mm FDA UDI
Identifiers
- Catalog Number
- FS-BDB-8X4 FDA UDI
- Primary DI / UDI-DI
- 00827002492219 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00827002492219 EUDAMED
- FDA Product Code
- FGE FDA UDI
- EMDN Code
- G0301010402 BILIARY BALLOON CATHETERS, HIGH PRESSURE EUDAMED
- GMDN Term
- Gastrointestinal/biliary dilation balloon catheter, non-medicated FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5010 FDA UDI
- Market of Registration
- Germany 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
Yes
FDA UDI
Category: Gastrointestinal/biliary dilation balloon catheter, non-medicated
Fusion Titan by Cook Incorporated — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Gastrointestinal/biliary dilation balloon catheter, non-medicated.
- Disposable Dilation Balloon — Micro-Tech (Nanjing) Co., Ltd. · Class II
- Disposable Dilation Balloon — Micro-Tech (Nanjing) Co., Ltd. · Class II
- FUJIFILM — FUJIFILM Corporation · Class II
- Flex-Ez Stylet Wire Balloon Dilator — HOBBS MEDICAL, INC. · Class II
- Disposable Dilation Balloon — Micro-Tech (Nanjing) Co., Ltd. · Class II
- Disposable Dilation Balloon — Micro-Tech (Nanjing) Co., Ltd. · Class II
- Reliant(TM) Multistage Dilatation Balloon Catheter — Micro-Tech (Nanjing) Co., Ltd. · Class II
- MaxForce TTS — Boston Scientific · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Cook Incorporated
Sources (2)
- FDA UDI 72f50840-c613-4042-84ac-e0717ee75db1 36 fields · synced Jul 8, 2026
- EUDAMED acdf0cf6-5fbc-49fd-a92d-bdb1eba7e087 61 fields · synced Jul 8, 2026