| Primary Device ID | 07540191000067 |
| NIH Device Record Key | f396233f-b876-411a-b201-1d99999c6b82 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | U-Control 60Hz Unit TT |
| Version Model Number | SA8825 |
| Company DUNS | 209284132 |
| Company Name | Technologie de Pensée Ltée |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| 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 |
|---|---|
| GS1 | 07540191000067 [Primary] |
| HIR | Perineometer |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-11-20 |
| Device Publish Date | 2017-08-31 |
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| 07540191000616 - Vaginal Pressure Probe | 2022-03-31 |
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| 07540191000562 - NEUROINFINITI 2 | 2020-07-24 |