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DuraSheath Introducer Sheath System
EUDAMEDFDA UDIClass III (EU MDR)
Ref FG-06045
Identity
- Trade Name
- DuraSheath Introducer Sheath System EUDAMEDFDA UDI
- Generic Name
- Vascular catheter introduction set, nonimplantable FDA UDI
- Device Name
- DuraSheath Introducer Sheath System EUDAMEDIntroducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1) dilator. FDA UDI
- Model / Reference
- FG-06045 EUDAMED6F, 45cm, straigth FDA UDI
- Description
- Introducer Sheath System containing One (1) introducer Sheath with haemostasis valve and One (1) dilator. FDA UDI
Identifiers
- Catalog Number
- FG-06045 FDA UDI
- Primary DI / UDI-DI
- 04251244500160 EUDAMEDFDA UDI
- Basic UDI-DI
- 4251244500000013C EUDAMED
- FDA Product Code
- DYB FDA UDI
- EMDN Code
- C0502 CARDIOVASCULAR INTRODUCER SHEATHS, VALVED EUDAMED
- GMDN Term
- Vascular catheter introduction set, nonimplantable FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1340 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
No
FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 2.25 Millimeter FDA UDILength — 45 Centimeter FDA UDI
DuraSheath Introducer Sheath System by Contract Medical International GmbH — Class III — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 4251244500000013C | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Contract Medical International GmbH
- EUDAMED SRN
- DE-MF-000007409
Sources (2)
- EUDAMED 1051b5a8-3922-4a5e-b51d-a0bfe63bd70a 61 fields · synced Jun 18, 2026
- FDA UDI bfe335d8-18f0-4049-bf05-6d58aba86c31 37 fields · synced May 30, 2026