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Penumbra ENGINE Canister – Penumbra System
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref PAPS3Model Penumbra ENGINE Canister – Penumbra System
Identity
- Trade Name
- Penumbra ENGINE Canister – Penumbra System EUDAMEDPenumbra System FDA UDI
- Generic Name
- Surgical irrigation/aspiration pump, reusable FDA UDI
- Device Name
- Penumbra ENGINE Canister EUDAMEDPS Engine Canister Assembly, CE FDA UDI
- Model / Reference
- Penumbra ENGINE Canister – Penumbra System EUDAMEDPAPS3 EUDAMEDFDA UDI
- Description
- PS Engine Canister Assembly, CE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814548019758 EUDAMEDFDA UDI
- Basic UDI-DI
- 081454801PSCAN8Q EUDAMED
- 510(k) Number
- K180008 FDA UDI
- FDA Product Code
- NRY FDA UDI
- EMDN Code
- A060199 SURGICAL DRAINAGE SYSTEMS - OTHER EUDAMED
- GMDN Term
- Surgical irrigation/aspiration pump, reusable FDA UDI
Classification
- Device Class
- Class I 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
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
Yes
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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Penumbra ENGINE Canister – Penumbra System by Penumbra, Inc. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K180008 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K072718 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 081454801PSCAN8Q | Class I | Active |
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Manufacturer
- Manufacturer
- Penumbra, Inc.
- EUDAMED SRN
- US-MF-000008514
- Authorised Representative
- Penumbra Europe GmbH DE-AR-000004997
Sources (3)
- EUDAMED a44bcf5e-218a-4641-9da9-bf51b1548a15 61 fields · synced Jul 9, 2026
- FDA UDI 0dbd4f08-6c4f-4754-9c25-f1e2433e2e81 34 fields · synced May 30, 2026
- FDA 510(k) K180008 1 fields · synced May 18, 2026