| Primary Device ID | 08852961029819 |
| NIH Device Record Key | 31d9b79d-4270-47ba-9598-bb4dab124681 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lelo Hex Lubricated Natural Rubber Latex Condom 36’s |
| Version Model Number | 36s |
| Company DUNS | 508701849 |
| Company Name | Leloi AB |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08852961029819 [Primary] |
| 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 | 2025-04-10 |
| Device Publish Date | 2025-04-02 |
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| 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 |
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