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Penumbra System
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref PODH1Model Penumbra Coil Detachment Handle
Identity
- Trade Name
- Penumbra Coil Detachment Handle EUDAMEDPenumbra System FDA UDI
- Generic Name
- Embolization implant kit FDA UDI
- Device Name
- Detachment Handle EUDAMEDPOD Detachment Handle FDA UDI
- Model / Reference
- PODH1 EUDAMEDFDA UDIPenumbra Coil Detachment Handle EUDAMED
- Description
- POD Detachment Handle FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815948025417 EUDAMEDM424PODH10 FDA UDI
- Basic UDI-DI
- 081454801PODHA7 EUDAMED
- 510(k) Number
- K141134 FDA UDI
- FDA Product Code
- HCG FDA UDI
- EMDN Code
- C010402020301 EMBOLISATION COILS EUDAMED
- GMDN Term
- Embolization implant kit FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 882.5950 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
Yes
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
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: Embolization implant kit
Penumbra System by Penumbra, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Embolization implant kit.
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Cleared under the same submission
K141134 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Penumbra, Inc.
Sources (2)
- FDA UDI 7d731665-cf99-4884-9489-4cfa7188356c 34 fields · synced Jul 30, 2026
- EUDAMED 8fa27a94-b6ca-48c4-80f8-4f9a15694f74 61 fields · synced Jul 30, 2026