This page includes the latest FDA filings for Insightra Medical. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
Insightra Medical holds import registrations or U.S. agent authorizations in conjunction with the following organizations:
| Registration Number | 3002067656 |
| FEI Number | 3002067656 |
| Name | LEAN SRL |
| Owner & Operator | Insightra Medical |
| Contact Address | 141 Hatcher Lane Clarksville TN 37043 US |
| Official Correspondent |
|
| US Agent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | Via Guglielmo Marconi 2 Medolla Modena, 41036 IT |
| Establishment Type | Manufacture Medical Device for Another Party (Contract Manufacturer) |
Device Company | Device | Date |
|---|---|---|
Insightra Medical | Insightra Freedom Ventral Hernia Repair System | 2015-05-07 |
Insightra Medical | FREEDOM INGUINAL HERNIA REPAIR IMPLANT-25MM/40MM/40MM WITH EXTENDED DISK | 2014-06-10 |
LEAN SRL [Insightra Medical] | Unit shield | 2013-01-31 |
LEAN SRL [Insightra Medical] | Power pump | 2013-01-31 |
LEAN SRL [Insightra Medical] | Interface cable | 2013-01-31 |
LEAN SRL [Insightra Medical] | Interface box | 2013-01-31 |
LEAN SRL [Insightra Medical] | Foot control | 2013-01-31 |
LEAN SRL [Insightra Medical] | DoublePump RF | 2013-01-31 |
Insightra Medical | FREEDOM INGUINAL HERNIA IMPLANT | 2012-08-23 |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 2019031445211 | Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina | OFFICE DOCUMENTS AND EQUIPMENT HS CODE NO. 48 209000 | 79 PKG |
| 2019031445211 | Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina | MEDICAL SUPPLIES HS CODE. NO 90219090 | 79 PKG |
| 2018081472112 | Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina | = 10 PALLETS MEDICAL EQUIPMENT | 1 PKG |