| Primary Device ID | 08800019116059 |
| NIH Device Record Key | 1386afe4-17ab-4145-973a-fd360d70871b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | B&Lite S |
| Version Model Number | B&Lite S |
| Company DUNS | 687338285 |
| Company Name | B& L Biotech, inc. |
| 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 | 08800019116059 [Primary] |
| EBZ | Activator, Ultraviolet, For Polymerization |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-22 |
| Device Publish Date | 2023-06-14 |
| 08800019110651 - POMO Black | 2023-06-23 |
| 08800019110668 - POMO White | 2023-06-23 |
| 08800019110675 - POMO Pink | 2023-06-23 |
| 08800019110712 - COMO Black | 2023-06-23 |
| 08800019110729 - COMO White | 2023-06-23 |
| 08800019110736 - COMO Pink | 2023-06-23 |
| 08800019110743 - COMO Tip | 2023-06-23 |
| 08800019110750 - COMO Tip | 2023-06-23 |