| Primary Device ID | 00827160115012 |
| NIH Device Record Key | f1a27998-dcd7-4dcb-876b-e6b7407193b8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | pjur ORIGINAL Sachetcard 2021, 1,5ml USA |
| Version Model Number | pjur ORIGINAL Sachetcard 2021, 1,5ml USA |
| Company DUNS | 400744553 |
| Company Name | Pjur Group Luxembourg SA |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| 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 | 00827160115012 [Primary] |
| NUC | Lubricant, Personal |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-08-02 |
| Device Publish Date | 2021-07-23 |
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| 10827160115255 - pjur INFINITY silicone-based | 2022-11-14 Silicone-based Personal Lubricant |
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| 10827160115170 - pjur INFINITY water-based | 2022-10-03 water-based Personal Lubricant |