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Penumbra Coil 400

FDA UDI

Class II (US FDA UDI)

by Penumbra, Inc.

Identity

Trade Name
Penumbra Coil 400 FDA UDI
Generic Name
Embolization implant kit FDA UDI
Device Name
PC400 Curve Sft, 3x4 FDA UDI
Model / Reference
4006U0304 FDA UDI
Description
PC400 Curve Sft, 3x4 FDA UDI

Identifiers

Primary DI / UDI-DI
M4244006U03040 FDA UDI
510(k) Number
K103305 FDA UDI
FDA Product Code
HCG FDA UDI
GMDN Term
Embolization implant kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5950 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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
MRI Safety
MR Conditional FDA UDI

Category: Embolization implant kit

Penumbra Coil 400 by Penumbra, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Embolization implant kit.

Cleared under the same submission

K103305 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Penumbra, Inc.

Sources (1)

  • FDA UDI 4ab27e5e-c789-4949-989c-6e7e2bff32dc 34 fields · synced May 29, 2026