Indigo System Lightning Bolt 16 LITNGFB16X100H1

GUDID 00810169722503

Indigo System Lightning Bolt 16 Aspiration Tubing, Aspiration Catheter 16 100cm XTORQ Tip, Select+ 120cm H1 Tip

PENUMBRA, INC.

Thrombectomy suction catheter
Primary Device ID00810169722503
NIH Device Record Key6e12b275-4973-4aad-9e9b-91ca8e3defaf
Commercial Distribution StatusIn Commercial Distribution
Brand NameIndigo System Lightning Bolt 16
Version Model NumberLITNGFB16X100H1-A
Catalog NumberLITNGFB16X100H1
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-888-272-4606
Emailinfo@penumbrainc.com
Phone1-888-272-4606
Emailinfo@penumbrainc.com
Phone1-888-272-4606
Emailinfo@penumbrainc.com
Phone1-888-272-4606
Emailinfo@penumbrainc.com
Phone1-888-272-4606
Emailinfo@penumbrainc.com
Phone1-888-272-4606
Emailinfo@penumbrainc.com
Phone1-888-272-4606
Emailinfo@penumbrainc.com
Phone1-888-272-4606
Emailinfo@penumbrainc.com
Phone1-888-272-4606
Emailinfo@penumbrainc.com
Phone1-888-272-4606
Emailinfo@penumbrainc.com
Phone1-888-272-4606
Emailinfo@penumbrainc.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810169722503 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QEWPeripheral Mechanical Thrombectomy With Aspiration

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-02
Device Publish Date2025-11-24

On-Brand Devices [Indigo System Lightning Bolt 16]

00810169722510Indigo System Lightning Bolt 16 Aspiration Tubing, Aspiration Catheter 16 80cm HTORQ Tip, Select
00810169722503Indigo System Lightning Bolt 16 Aspiration Tubing, Aspiration Catheter 16 100cm XTORQ Tip, Selec
00810169722497Indigo System Lightning Bolt 16 Aspiration Tubing, Aspiration Catheter 16 100cm HTORQ Tip, Selec
00810169722480Indigo System Lightning Bolt 16 Aspiration Tubing, Aspiration Catheter 16 115cm HTORQ Tip, Selec

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