| Primary Device ID | 07350075028946 |
| NIH Device Record Key | 7db8a52a-e64b-4e5f-a926-25dd207712c2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Tor 3 Violet Dusk |
| Version Model Number | 8946 |
| Company DUNS | 508701849 |
| Company Name | Leloi AB |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07350075028946 [Primary] |
| LKY | Device, External Penile Rigidity |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-04 |
| Device Publish Date | 2023-06-26 |
| 08852961029796 - Lelo Hex Lubricated Natural Rubber Latex Condom 3’s | 2025-04-10 The Lelo Hex Lubricated Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pre |
| 08852961029802 - Lelo Hex Lubricated Natural Rubber Latex Condom 12’s | 2025-04-10 The Lelo Hex Lubricated Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pre |
| 08852961029819 - Lelo Hex Lubricated Natural Rubber Latex Condom 36’s | 2025-04-10 The Lelo Hex Lubricated Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pre |
| 07350075029578 - HEX Condoms Original 72 Pack (US_TNR) | 2023-07-18 The Lelo Hex Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and |
| 07350075028922 - Tor 3 Black | 2023-07-04 Intended to be placed at the base of the penis where it will stimulate the clitoris of partner to facilitate human sexual pleasu |
| 07350075028939 - Tor 3 Base Blue | 2023-07-04 Intended to be placed at the base of the penis where it will stimulate the clitoris of partner to facilitate human sexual pleasu |
| 07350075028946 - Tor 3 Violet Dusk | 2023-07-04Intended to be placed at the base of the penis where it will stimulate the clitoris of partner to facilitate human sexual pleasure. The ring shall be able to be placed around the penis at the base, primarily to slow the flow of blood from the erect penile tissue, thus maintaining an erection for a much longer period of time. Plus a vibrator to facilitate human sexual pleasure. |
| 07350075028946 - Tor 3 Violet Dusk | 2023-07-04 Intended to be placed at the base of the penis where it will stimulate the clitoris of partner to facilitate human sexual pleasu |
| 07350075029219 - Intimina KegelSmart 2 Rechargeable | 2023-07-04 The Intimina KegelSmart 2 is a pelvic floor muscle exercise device that provides biofeedback and exercise guidance. Each time th |