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6F Benchmark 95cm Straight
EUDAMEDFDA UDIClass III (EU MDR)
Ref BMK6F95Model Delivery Catheter
Identity
- Trade Name
- 6F Benchmark 95cm Straight EUDAMEDBenchmark FDA UDI
- Generic Name
- Vascular microcatheter FDA UDI
- Device Name
- Benchmark Intracranial Access System EUDAMEDBmk70 STR, 95cm FDA UDI
- Model / Reference
- Delivery Catheter EUDAMEDBMK6F95 EUDAMEDFDA UDI
- Description
- Bmk70 STR, 95cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- D-BenchmarkG6 EUDAMED00814548014111 FDA UDI
- Basic UDI-DI
- B-BenchmarkG6 EUDAMED
- 510(k) Number
- K142321 FDA UDI
- FDA Product Code
- DQY FDA UDI
- EMDN Code
- C010480 ANGIOGRAPHY AND HEMODYNAMICS DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
- GMDN Term
- Vascular microcatheter FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1250 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
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Vascular guidewire introduction sleeve
6F Benchmark 95cm Straight by Penumbra, Inc. — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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-BenchmarkG6 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Penumbra, Inc.
- EUDAMED SRN
- US-MF-000008514
- Authorised Representative
- Penumbra Europe GmbH DE-AR-000004997
Sources (2)
- EUDAMED e8d710f3-4b4a-4521-aad3-665d8d1016a6 61 fields · synced Aug 2, 2026
- FDA UDI 517633b2-ff33-4645-bb34-952facd405bd 34 fields · synced May 30, 2026