| Primary Device ID | 00810026183775 |
| NIH Device Record Key | a388b996-b18d-416b-b223-108f90381804 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bleph kit |
| Version Model Number | SBK-01 |
| Catalog Number | SBK-01 |
| Company DUNS | 117308190 |
| Company Name | SONIQUENCE, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810026183775 [Primary] |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-16 |
| Device Publish Date | 2023-10-06 |
| 00810026183669 - SP-Tip | 2023-10-16 SP-Tip |
| 00810026183706 - Soni-Cerv | 2023-10-16 LEEP Ball electrode |
| 00810026183775 - Bleph kit | 2023-10-16Bleph Kit |
| 00810026183775 - Bleph kit | 2023-10-16 Bleph Kit |
| 00810026180248 - Blepharoplasty kit | 2023-04-04 Blepharoplasty Kit |
| 00810026180972 - Reusable Handpiece | 2023-04-04 Reusable Handpiece |
| 00810026181535 - RF Generator | 2023-04-04 RF Generator |
| 00810026181542 - RF Generator | 2023-04-04 RF Generator |
| 00810026181559 - RF Generator | 2023-04-04 RF Generator |