| 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 |
| M8030030134 - Baby Tischler Biopsy Punch Titanium | 2025-11-24 Baby Tischler Biopsy Punch Titanium 10" (254mm) - Angled Up |
| M8030030139 - Tischler Biopsy Punch Titanium | 2025-11-24 Tischler Biopsy Punch Titanium 8 1/2" (216mm) - Angled Left |
| M803029801 - Tischler Biopsy Punch | 2025-11-24 Tischler Biopsy Punch 10" (254mm) Up |
| M803029802 - Tischler Biopsy Punch | 2025-11-24 Tischler Biopsy Punch 10" (254mm) Down |
| M803029803 - Tischler Biopsy Punch | 2025-11-24 Tischler Biopsy Punch 10" (254mm) Left |
| M803029804 - Tischler Biopsy Punch | 2025-11-24 Tischler Biopsy Punch 10" (254mm) Right |
| M803029811 - Baby Tischler Biopsy Punch | 2025-11-24 Baby Tischler Biopsy Punch 10" (254mm) Up |
| M803029812 - Baby Tischler Biopsy Punch | 2025-11-24 Baby Tischler Biopsy Punch 10" (254mm) Down |