| Primary Device ID | 07350075025075 |
| NIH Device Record Key | 179a5e24-4ddb-42ef-86ac-2ed1134cf182 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LELO HEX RE-ENGINEERED LATEX RESPECT CONDOM - 6 PACK |
| Version Model Number | 4993 |
| Company DUNS | 508701849 |
| Company Name | Leloi AB |
| Device Count | 6 |
| 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 | 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 | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07350075024085 [Primary] |
| GS1 | 07350075024993 [Primary] |
| GS1 | 07350075025075 [Unit of Use] |
| HIS | Condom |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-06-03 |
| Device Publish Date | 2022-05-26 |
| 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 | 2023-07-04 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 |