Identity
- Trade Name
- Fortress® EUDAMEDBiotronik Fortress Introducer Sheath System FDA UDI
- Generic Name
- Vascular catheter introduction set, nonimplantable FDA UDI
- Device Name
- Fortress Introducer Sheath EUDAMEDIntroducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1) dilator. FDA UDI
- Model / Reference
- FG-06551-001A EUDAMED386594 EUDAMED45 cm, 6F Straight FDA UDI
- Description
- Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1) dilator. FDA UDI
Identifiers
- Catalog Number
- 386594 FDA UDI
- Primary DI / UDI-DI
- 04251244500078 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04251244500078 EUDAMED
- FDA Product Code
- DYB FDA UDI
- EMDN Code
- C0599 CARDIOVASCULAR INTRODUCER SHEATHS - OTHER EUDAMED
- GMDN Term
- Vascular catheter introduction set, nonimplantable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1340 FDA UDI
- Market of Registration
- Austria 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
No
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
- Lumen/Inner Diameter — 2.28 Millimeter FDA UDILength — 45 Centimeter FDA UDI
Fortress® by Contract Medical International GmbH — Class IIa — 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-04251244500078 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Contract Medical International GmbH
- EUDAMED SRN
- DE-MF-000007409
Sources (2)
- EUDAMED 8e568b12-0207-402b-bcf4-88fb4c9fbe2f 61 fields · synced May 31, 2026
- FDA UDI e4aa74a7-6bf5-47f8-86ba-4e41f042bccb 37 fields · synced May 26, 2026