| Primary Device ID | 00837654352885 |
| NIH Device Record Key | 1f6ae4ed-16ed-4dc4-8c3f-2e9af9fea6dd |
| Commercial Distribution Discontinuation | 2019-12-05 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Freedom - ProFlor Inguinal Hernia Kit |
| Version Model Number | FIHR 40mmK |
| Catalog Number | FIHR 40mmK |
| Company DUNS | 097664937 |
| Company Name | INSIGHTRA MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Outer Diameter | 40 Millimeter |
| Outer Diameter | 40 Millimeter |
| Outer Diameter | 40 Millimeter |
| Outer Diameter | 40 Millimeter |
| Outer Diameter | 40 Millimeter |
| Outer Diameter | 40 Millimeter |
| Outer Diameter | 40 Millimeter |
| Outer Diameter | 40 Millimeter |
| Outer Diameter | 40 Millimeter |
| Outer Diameter | 40 Millimeter |
| Outer Diameter | 40 Millimeter |
| Outer Diameter | 40 Millimeter |
| Outer Diameter | 40 Millimeter |
| Outer Diameter | 40 Millimeter |
| Outer Diameter | 40 Millimeter |
| Outer Diameter | 40 Millimeter |
| Outer Diameter | 40 Millimeter |
| Outer Diameter | 40 Millimeter |
| Outer Diameter | 40 Millimeter |
| Outer Diameter | 40 Millimeter |
| Outer Diameter | 40 Millimeter |
| Outer Diameter | 40 Millimeter |
| Outer Diameter | 40 Millimeter |
| Outer Diameter | 40 Millimeter |
| Outer Diameter | 40 Millimeter |
| Outer Diameter | 40 Millimeter |
| Outer Diameter | 40 Millimeter |
| Outer Diameter | 40 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 0013964672053 [Package] Package: [6 Units] Discontinued: 2019-12-05 Not in Commercial Distribution |
| GS1 | 00837654352885 [Primary] |
| FTL | Mesh, Surgical, Polymeric |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-12-06 |
| Device Publish Date | 2015-07-22 |
| 00837654352885 | The Insightra Medical Freedom Inguinal Hernia Implant (ProFlor™) is a sterile, polypropylene i |
| 00837654352878 | The Insightra Medical Freedom Inguinal Hernia Implant (ProFlor™) is a sterile, polypropylene i |
| 00013964672367 | The Insightra Medical Freedom Inguinal Hernia Implant (ProFlor™) is a sterile, polypropylene i |
| 00013964672152 | The Insightra Medical Freedom Inguinal Hernia Implant (ProFlor™) is a sterile polypropylene im |