| Primary Device ID | M803TMI1151 |
| NIH Device Record Key | 938fa78a-ca6b-4299-b3a7-84feb49020d2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Uterine Manipulator |
| Version Model Number | Uterine Manipulator/ Injector |
| Catalog Number | TMI1151 |
| Company DUNS | 103913430 |
| Company Name | MEDGYN PRODUCTS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M803TMI1151 [Primary] |
| LKF | Cannula, Manipulator/Injector, Uterine |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-06-27 |
| Device Publish Date | 2022-06-17 |
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| M803LE04105 - Loop Electrodes 10X5mm | 2024-01-11 Loop Electrodes 10X5mm Box 20 |
| M803LE05101 - Loop Electrodes 10x10mm | 2024-01-11 Loop Electrodes 10x10mm Box 20 |
| M803LE06101 - Square Electrodes 10x10mm | 2024-01-11 Square Electrodes 10x10mm SQ Box 20 |
| M803LE06108 - Square Electrodes 10x8mm | 2024-01-11 Square Electrodes 10x8mm SQ Box 20 |
| M803LE07158 - Loop Electrodes 15x8mm | 2024-01-11 Loop Electrodes 15x8mm Box 20 |
| M803LE09208 - Loop Electrodes 20x8mm | 2024-01-11 Loop Electrodes 20x8mm Box 20 |