Penumbra System

FDA UDI

Class II (US FDA UDI)

by Penumbra, Inc.

Identity

Trade Name: Penumbra System FDA UDI
Generic Name: Thrombectomy suction catheter FDA UDI
Device Name: 5MAXJET7L120-B FDA UDI
Model / Reference: 5MAXJET7L120-B FDA UDI
Description: 5MAXJET7L120-B FDA UDI

Identifiers

Primary DI / UDI-DI: 00815948020924 FDA UDI
FDA Product Code: NRY FDA UDI
GMDN Term: Thrombectomy suction catheter FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1250 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Category: Thrombectomy suction catheter

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

Similar devices

Also classified as Thrombectomy suction catheter.

Symphony™ ProHelix™ — IMPERATIVE CARE INC. · Class II
Prodigy™ Catheter — IMPERATIVE CARE INC. · Class II
Symphony™ Advance™ Long Dilator — IMPERATIVE CARE INC. · Class II
Trevo — Stryker Corp.
Pounce ™ Thrombectomy — Surmodics, Inc. · Class II
Solitaire™ — Micro Therapeutics, Inc. · Class II
Stroke Fast Pack — Stryker Corp.
SmartClaw™ — Boston Scientific · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Penumbra, Inc.

Sources (1)

FDA UDI 5dac0322-3e78-4166-bbf0-4c6d8029d8de 33 fields · synced Jun 6, 2026