Systems Configuration

GUDID 00815948020061

PENUMBRA, INC.

Thrombectomy suction catheter
Primary Device ID00815948020061
NIH Device Record Key12b24dae-99d5-4640-ae59-602a4fff8976
Commercial Distribution StatusIn Commercial Distribution
Brand NameSystems Configuration
Version Model NumberACE603DVELSYS-A
Company DUNS191077671
Company NamePENUMBRA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100815948020061 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NRYCatheter, Thrombus Retriever

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-03-21
Device Publish Date2018-01-26

Devices Manufactured by PENUMBRA, INC.

00810169722480 - Indigo System Lightning Bolt 162025-12-02 Indigo System Lightning Bolt 16 Aspiration Tubing, Aspiration Catheter 16 115cm HTORQ Tip, Select+ 135cm H1 Tip
00810169722497 - Indigo System Lightning Bolt 162025-12-02 Indigo System Lightning Bolt 16 Aspiration Tubing, Aspiration Catheter 16 100cm HTORQ Tip, Select+ 120cm H1 Tip
00810169722503 - Indigo System Lightning Bolt 162025-12-02 Indigo System Lightning Bolt 16 Aspiration Tubing, Aspiration Catheter 16 100cm XTORQ Tip, Select+ 120cm H1 Tip
00810169722510 - Indigo System Lightning Bolt 162025-12-02 Indigo System Lightning Bolt 16 Aspiration Tubing, Aspiration Catheter 16 80cm HTORQ Tip, Select+ 100cm H1 Tip
00810169722527 - Indigo System Lightning Flash2025-12-02 Indigo System Lightning Flash Aspiration Tubing, Aspiration Catheter 16 115cm HTORQ Tip, Select+ 135cm H1 Tip
00810169722534 - Indigo System Lightning Flash2025-12-02 Indigo System Lightning Flash Aspiration Tubing, Aspiration Catheter 16 100cm HTORQ Tip, Select+ 120cm H1 Tip
00810169722541 - Indigo System Lightning Flash2025-12-02 Indigo System Lightning Flash Aspiration Tubing, Aspiration Catheter 16 100cm XTORQ Tip, Select+ 120cm H1 Tip
00810169722558 - Indigo System Lightning Flash2025-12-02 Indigo System Lightning Flash Aspiration Tubing, Aspiration Catheter 16 80cm HTORQ Tip, Select+ 100cm H1 Tip

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