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Penumbra System
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref SCH1Model Penumbra Smart Coil Detachment Handle
Identity
- Trade Name
- Penumbra Smart Coil Detachment Handle EUDAMEDPenumbra System FDA UDI
- Generic Name
- Embolization implant kit FDA UDI
- Device Name
- Detachment Handle EUDAMEDSmtCoil Handle FDA UDI
- Model / Reference
- SCH1 EUDAMEDFDA UDIPenumbra Smart Coil Detachment Handle EUDAMED
- Description
- SmtCoil Handle FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815948027596 EUDAMED00814548016139 FDA UDI
- Basic UDI-DI
- 081454801SCHEV EUDAMED
- 510(k) Number
- K143218 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
K143218 also covers:
- Smart Coil — PENUMBRA, INC.
- Smart Coil — PENUMBRA, INC.
- Smart Coil — PENUMBRA, INC.
- Smart Coil — PENUMBRA, INC.
- Smart Coil — PENUMBRA, INC.
- Smart Coil — PENUMBRA, INC.
- Smart Coil — PENUMBRA, INC.
- Smart Coil — PENUMBRA, INC.
- Smart Coil — PENUMBRA, INC.
- Smart Coil — PENUMBRA, INC.
- Smart Coil — PENUMBRA, INC.
- Smart Coil — PENUMBRA, INC.
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 cc37c603-fb5f-45d1-b268-6f54fdb6d8e0 34 fields · synced Jun 18, 2026
- EUDAMED 7d4077a7-821b-46b9-9cc4-ea4f36d4c37f 61 fields · synced Jun 18, 2026