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Fortress Introducer Sheath System
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 452386Ref 452383Ref 358814Ref 358813Ref 452389Ref 452385Ref 386593Ref 444481Ref 386590Ref 452384Ref 386594Ref 452387Ref 444484Ref 444485
Identity
- Trade Name
- Fortress Introducer Sheath System EUDAMEDFortress Introducer Sheath EUDAMEDBiotronik Fortress Introducer Sheath System FDA UDI
- Generic Name
- Vascular catheter introduction set, nonimplantable FDA UDI
- Device Name
- Fortress Introducer Sheath System EUDAMEDIntroducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1) dilator. FDA UDIIntroducer Sheath System containing One (1) introducer Sheath with haemostasis valve and Two (2) dilators. FDA UDI
- Model / Reference
- 452386 EUDAMED452383 EUDAMED358814 EUDAMED358813 EUDAMED452389 EUDAMED452385 EUDAMED386593 EUDAMED444481 EUDAMED386590 EUDAMED452384 EUDAMED386594 EUDAMED452387 EUDAMED444484 EUDAMED444485 EUDAMED5F; 45 cm; crossover FDA UDI7F; 45 cm; crossover FDA UDI8F; 45 cm; straight FDA UDI8F; 90 cm; straight FDA UDI6F; 45 cm; crossover FDA UDI4F; 45 cm; straight FDA UDI5F; 65 cm; straight FDA UDI4F; 45 cm; crossover FDA UDI8F; 65 cm; straight FDA UDI6F; 45 cm; straight FDA UDI6F; 90 cm; straight FDA UDI4F; 90 cm; straight FDA UDI8F; 45 cm; crossover FDA UDI7F; 65 cm; straight FDA UDI7F; 45 cm; straight FDA UDI
- Description
- Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1) dilator. FDA UDIIntroducer Sheath System containing One (1) introducer Sheath with haemostasis valve and Two (2) dilators. FDA UDI
Identifiers
- Catalog Number
- 386590 FDA UDI452386 FDA UDI452385 FDA UDI452389 FDA UDI386593 FDA UDI358814 FDA UDI444484 FDA UDI358813 FDA UDI452384 FDA UDI386594 FDA UDI444481 FDA UDI444485 FDA UDI452387 FDA UDI452383 FDA UDI452382 FDA UDI
- Primary DI / UDI-DI
- 04251244503758 EUDAMEDFDA UDI04251244503789 EUDAMEDFDA UDI04251244503604 EUDAMEDFDA UDI04251244503628 EUDAMEDFDA UDI04251244503772 EUDAMEDFDA UDI04251244503840 EUDAMEDFDA UDI04251244503802 EUDAMEDFDA UDI04251244503727 EUDAMEDFDA UDI04251244503741 EUDAMEDFDA UDI04251244503673 EUDAMEDFDA UDI04251244503680 EUDAMEDFDA UDI04251244503833 EUDAMEDFDA UDI04251244503703 EUDAMEDFDA UDI04251244503642 EUDAMEDFDA UDI04251244503826 EUDAMEDFDA UDI
- Basic UDI-DI
- 4251244500000113F EUDAMED
- 510(k) Number
- K153197 FDA UDI
- FDA Product Code
- DYB FDA UDIDRE FDA UDI
- EMDN Code
- C0502 CARDIOVASCULAR INTRODUCER SHEATHS, VALVED EUDAMED
- GMDN Term
- Vascular catheter introduction set, nonimplantable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1340 FDA UDI870.1310 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
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
Yes
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 — 45 Centimeter FDA UDILumen/Inner Diameter — 1.95 Millimeter FDA UDILumen/Inner Diameter — 2.55 Millimeter FDA UDILumen/Inner Diameter — 2.88 Millimeter FDA UDILength — 90 Centimeter FDA UDILumen/Inner Diameter — 2.20 Millimeter FDA UDILumen/Inner Diameter — 1.62 Millimeter FDA UDILength — 65 Centimeter FDA UDI
Category: Vascular catheter introduction set, nonimplantable
Fortress Introducer Sheath System by Contract Medical International GmbH — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Also classified as Vascular catheter introduction set, nonimplantable.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 4251244500000113F | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 4251244500000113F | 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 (40)
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