| Primary Device ID | B296M03560 |
| NIH Device Record Key | b6ce7674-5fc0-4628-a760-e4c11e257071 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CUSTOM ASSEMBLIES HSG |
| Version Model Number | M0356 |
| Company DUNS | 080306309 |
| Company Name | TITUS MEDICAL LLC |
| 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B296M03560 [Primary] |
| LKF | Cannula, Manipulator/Injector, Uterine |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-01-20 |
| 00850011427217 - IMA HSG Catheters | 2024-04-11 HSG / SIS Catheters 5fr |
| 00850011427194 - SonoInject Catheter HSG | 2024-04-08 SIS or HSG single Lumen Catheter 5fr |
| 10850011427146 - HSG/SIS Trays/Kits with 5Fr catheter | 2021-04-05 Case of 10 HSG/SIS Trays/Kits with 5Fr catheter |
| 10850011427153 - HSG Trays/Kits 7fr | 2021-04-05 Case of 10 HSG/SIS Trays/Kits with 7Fr catheter |
| B296063000 - 10 HSG/SIS Procedure Trays | 2021-04-05 Box of 10 HSG/SIS Procedure Trays with No Catheter Included |
| B296063001 - 1 HSG/SIS Tray No Catheter | 2021-04-05 1 HSG/SIS Tray No Catheter included |
| B296063051 - HSG/SIS Tray/Kit with 5fr HSG Catheter | 2021-04-05 1 HSG/SIS Tray/Kit with 5fr HSG Catheter |
| B296063071 - HSG/SIS Tray with 7fr Catheter | 2021-04-05 1 HSG/SIS Tray with 7fr Catheter |