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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
Non-neurovascular embolization coil FDA UDI
Device Name
Ruby Coil LP, 1 mm x 5 cm FDA UDI
Model / Reference
RBYLP0105-B FDA UDI
Description
Ruby Coil LP, 1 mm x 5 cm FDA UDI

Identifiers

Primary DI / UDI-DI
00815948025967 FDA UDI
510(k) Number
K192955 FDA UDI
K230284 FDA UDI
FDA Product Code
HCG FDA UDI
KRD FDA UDI
GMDN Term
Non-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 21e9a9eb-29e6-4211-b3b5-2557f40c4c7c 34 fields · synced May 30, 2026