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LP Coil System

FDA UDI

Class II (US FDA UDI)

by Penumbra, Inc.

Identity

Trade Name
LP Coil System FDA UDI
Generic Name
Neurovascular embolization coil FDA UDI
Device Name
Ruby Coil LP, 5 mm x 10 cm FDA UDI
Model / Reference
RBYLP0510-B FDA UDI
Description
Ruby Coil LP, 5 mm x 10 cm FDA UDI

Identifiers

Primary DI / UDI-DI
00815948026063 FDA UDI
510(k) Number
K192955 FDA UDI
K230284 FDA UDI
FDA Product Code
HCG FDA UDI
KRD FDA UDI
GMDN Term
Neurovascular embolization coil FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5950 FDA UDI
870.3300 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Neurovascular embolization coilNon-neurovascular embolization coil

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

Similar devices

Also classified as Non-neurovascular embolization coil.

Cleared under the same submission

K192955 also covers:

K230284 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 571b6459-9166-4e28-b366-098edd31e874 34 fields · synced May 30, 2026