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INSIGHTRA MEDICAL, INC.

Last updated September 17, 2026

Information

Country: US
Address: 2543 Madison St, Clarksville, TN, 37043
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3003945344
DUNS Number: —

Catalogue (59)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
Freedom - Ventral Hernia Repair System	FVHR15X25	FDA UDI	Class II	Active
Double Pump Day cassette/ Double Pump RF Day cassette	1002053	FDA UDI	Class II	Active
PowerPumpTM dp System Patient tubing	941014	FDA UDI	Class II	Active
RF Cable A2	1402007	FDA UDI	Class II	Active
PowerPumpTM dp System Power Pump dp HP Interface Box Type 3	941023G	FDA UDI	Class II	Active
Freedom - ProFlor Inguinal Hernia Kit	FIHR 40mmEK	FDA UDI	Class II	Unknown
Double Pump RF Patient cassette	1003059	FDA UDI	Class II	Active
Freedom - ProFlor Inguinal Hernia Implant	FIHR 40mmE	FDA UDI	Class II	Active
Ultra IABP Catheter Kit	IMU7F-35	FDA UDI	Class II	Active
Freedom - ProFlor Inguinal Hernia Kit	FIHR 25mmK	FDA UDI	Class II	Unknown
Double Pump Single/ Double Pump RF Single	1002052	FDA UDI	Class II	Active
PowerPumpTM dp System Power Pump dp HP Interface Box Type 1	941038G	FDA UDI	Class II	Active
Freedom - Ventral Hernia Repair System	FVHR35X45	FDA UDI	Class II	Active
Double Pump Patient cassette	1002059	FDA UDI	Class II	Active
PowerPumpTM dp System Foot Control	941040	FDA UDI	Class II	Active
Shaver Interface Box B2	1407201	FDA UDI	Class II	Active
Shaver Interface Box B10	1407208	FDA UDI	Class II	Active
Shaver interface Cable C2	1407251	FDA UDI	Class II	Active
PowerPumpTM dp System Interface Cable, Type 6	941034G	FDA UDI	Class II	Active
Freedom - Ventral Hernia Repair System	FVHR20X30	FDA UDI	Class II	Active
Freedom - ProFlor Inguinal Hernia Implant	FIHR 25mm	FDA UDI	Class II	Active
PowerPumpTM dp System Interface Cable, Type 5	941033G	FDA UDI	Class II	Active
PowerPumpTM dp System Day Cassette	941012	FDA UDI	Class II	Active
Shaver Interface Box B1	1407200	FDA UDI	Class II	Active
PowerPumpTM dp System Power Pump dp HP Interface Box Type 2	941015G	FDA UDI	Class II	Active
PowerPumpTM dp System	941010	FDA UDI	Class II	Active
Ultra IABP Catheter Kit	IMU7F-40	FDA UDI	Class II	Active
Modulare Stabilization Device	M-CVC/PICC	FDA UDI	Class I	Unknown
Modulare Stabilization Device	M-CVC/PICCSP	FDA UDI	Class I	Unknown
PowerPumpTM dp System Interface Cable, Type 3	941036G	FDA UDI	Class II	Active
Shaver interface Cable C8	1407257	FDA UDI	Class II	Active
Shaver interface Cable C5	1407254	FDA UDI	Class II	Active
PowerPumpTM dp System Interface Cable, Type 1	941037G	FDA UDI	Class II	Active
Shaver interface Cable C15	1407264	FDA UDI	Class II	Active
Freedom - ProFlor Inguinal Hernia Kit	FIHR 25mmEK	FDA UDI	Class II	Unknown
Shaver Interface Box B6	1407205	FDA UDI	Class II	Active
Freedom - Ventral Hernia Repair System	FVHR12X15	FDA UDI	Class II	Active
Freedom - ProFlor Inguinal Hernia Kit	FIHR 40mmK	FDA UDI	Class II	Unknown
Foot Control 2-pedal	1404003	FDA UDI	Class II	Active
Freedom - Ventral Hernia Repair System	FVHR28X35	FDA UDI	Class II	Active
Foot Control 4-pedal	1404176	FDA UDI	Class II	Active
PowerPumpTM dp System Power Pump dp HP Interface Box Type 4	941025G	FDA UDI	Class II	Active
Shaver interface Cable C1	1407250	FDA UDI	Class II	Active
Ultra IABP Catheter Kit	IMU7F-30	FDA UDI	Class II	Active
Shaver interface Cable C6	1407255	FDA UDI	Class II	Active
RF Cable A1	1402008	FDA UDI	Class II	Active
Double Pump RF	1028511	FDA UDI	Class II	Active
Freedom - ProFlor Inguinal Hernia Implant	FIHR 40mm	FDA UDI	Class II	Active
PowerPumpTM dp System Patient cassette	941013	FDA UDI	Class II	Active
Shaver Interface Box B5	1407204	FDA UDI	Class II	Active

Related Companies

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Authorities

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FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jul 19, 2025	Z-2298-2025	—	terminated	Device contains indications for use and device compatibility claims that have not be reviewed and approved for safety and effectiveness by the FDA. Instructions for use are not consistent with product training.