FDA.reportPublic FDA data

INSIGHTRA MEDICAL, INC.

Matched from indexed company URL: Insightra Medical

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20326773003945344INSIGHTRA MEDICAL, INC.1Y2026-01-012543 Madison St Unit 105 Clarksville TN US 37043

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00013964672077Modulare Stabilization Device - The Modulare System is used to secure various types of catheters to the patient’s skin. The device uses a post and securement cover to attach itself to either the suture tab of the catheter or mating hole on Modulare accessories. An adhesive base secures the Modulare system to the patient to allow for safe and secure placement of the catheter onto the patient. The Modulare system is disposable and designed to be placed on the patient for a time to not to exceed 7 days.949-215-1835raqa@insightra.com
00013964672077Modulare Stabilization Device - The Modulare System is used to secure various types of catheters to the patient’s skin. The device uses a post and securement cover to attach itself to either the suture tab of the catheter or mating hole on Modulare accessories. An adhesive base secures the Modulare system to the patient to allow for safe and secure placement of the catheter onto the patient. The Modulare system is disposable and designed to be placed on the patient for a time to not to exceed 7 days.931-919-2955wayne.lyle@insightra.com
00013964672152Freedom - ProFlor Inguinal Hernia Kit - The Insightra Medical Freedom Inguinal Hernia Implant (ProFlor™) is a sterile polypropylene implant device designed for use in the open repair of inguinal hernias. A delivery device is used to deploy the implant into the prepared hernia defect site.9319192955wayne.lyle@insightra.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
214361954423677K142192Insightra Freedom Ventral Hernia Repair SystemFTL2015-05-07
214361090456599K140967FREEDOM INGUINAL HERNIA REPAIR IMPLANT-25MM/40MM/40MM WITH EXTENDED DISKFTL2014-06-10
214361953020076K113552FREEDOM INGUINAL HERNIA IMPLANTFTL2012-08-23
214361881393505K093409POWERPUMP ARTHROSCOPY SYSTEMHRX2010-02-24
214362044825598K082746ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20DSP2009-01-12
214361920149902K080550MEGACHANNEL ENDOSCOPIC OVERTUBE, MODEL OT22ODB2008-06-10
214361330105085
214361907073360
214362009499510
214361144122102
214361533110885
214361641040749
214361717053345
214361868608592

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FTL32015-05-07
DSP22009-01-12
HRX12010-02-24
ODB12008-06-10

PMN#

GUDID#

Modulare Stabilization Device - The Modulare System is used to secure various types of catheters to the patient’s skin. The device uses a post and securement cover to attach itself to either the suture tab of the catheter or mating hole on Modulare accessories. An adhesive base secures the Modulare system to the patient to allow for safe and secure placement of the catheter onto the patient. The Modulare system is disposable and designed to be placed on the patient for a time to not to exceed 7 days.

INSIGHTRA MEDICAL, INC.

2015-03-16

Modulare Stabilization Device - The Modulare System is used to secure various types of catheters to the patient’s skin. The device uses a post and securement cover to attach itself to either the suture tab of the catheter or mating hole on Modulare accessories. An adhesive base secures the Modulare system to the patient to allow for safe and secure placement of the catheter onto the patient. The Modulare system is disposable and designed to be placed on the patient for a time to not to exceed 7 days.

INSIGHTRA MEDICAL, INC.

2015-03-16

62 records. Showing 1-40. Next