LimFlow Extension Stent Graft

GUDID 00850041730196

LimFlow Extension Stent Graft (5.5 mm x 100 mm). The LimFlow Extension Stent Graft is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.

Limflow Inc.

Arteriovenous endovascular stent-graft
Primary Device ID00850041730196
NIH Device Record Keyc8eada2d-ac0e-4a53-b534-b5e4d22566c3
Commercial Distribution StatusIn Commercial Distribution
Brand NameLimFlow Extension Stent Graft
Version Model NumberRGS-55100-US-24
Company DUNS096651686
Company NameLimflow Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
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

Phone18884787705
Emailinfo@limflow.com
Phone18884787705
Emailinfo@limflow.com
Phone18884787705
Emailinfo@limflow.com
Phone18884787705
Emailinfo@limflow.com
Phone18884787705
Emailinfo@limflow.com
Phone18884787705
Emailinfo@limflow.com
Phone18884787705
Emailinfo@limflow.com
Phone18884787705
Emailinfo@limflow.com
Phone18884787705
Emailinfo@limflow.com
Phone18884787705
Emailinfo@limflow.com
Phone18884787705
Emailinfo@limflow.com
Phone18884787705
Emailinfo@limflow.com
Phone18884787705
Emailinfo@limflow.com
Phone18884787705
Emailinfo@limflow.com
Phone18884787705
Emailinfo@limflow.com
Phone18884787705
Emailinfo@limflow.com
Phone18884787705
Emailinfo@limflow.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850041730196 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QWNStent Graft, Infrapopliteal, Venous Arterialization

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-16
Device Publish Date2024-10-08

On-Brand Devices [LimFlow Extension Stent Graft]

00850041730219LimFlow Extension Stent Graft (5.5 mm x 200 mm). The LimFlow Extension Stent Graft is indicated
00850041730202LimFlow Extension Stent Graft (5.5 mm x 150 mm). The LimFlow Extension Stent Graft is indicated
00850041730196LimFlow Extension Stent Graft (5.5 mm x 100 mm). The LimFlow Extension Stent Graft is indicated
00850041730189LimFlow Extension Stent Graft (5.5 mm x 60 mm). The LimFlow Extension Stent Graft is indicated f

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