| Primary Device ID | 08033638803318 |
| NIH Device Record Key | a7c90498-7a47-46ac-9269-f0e53a4f68b1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Self-Suction-LEM |
| Version Model Number | Self-Suction-LEM with 3 bands |
| Catalog Number | A.5670.3 |
| Company DUNS | 437320088 |
| Company Name | SAPI MED SPA |
| 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 | 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08033638803301 [Primary] |
| GS1 | 08033638803318 [Package] Contains: 08033638803301 Package: [25 Units] In Commercial Distribution |
| FHN | Ligator, Hemorrhoidal |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-04 |
| Device Publish Date | 2023-07-27 |
| 08033638800003 - Anoscope | 2023-11-17 Self-Light Diagnostic Proctoscope |
| 08033638800034 - Anoscope | 2023-11-17 Self-Light Diagnostic Proctoscope |
| 08033638800058 - Anoscope | 2023-11-17 Self-Light Surgical Protoscope |
| 08033638800072 - Anoscope | 2023-11-17 Self-Light Surgical Proctoscope |
| 08033638800096 - Retractor | 2023-11-17 Anal retractor |
| 08033638800119 - Retractor | 2023-11-17 Basile's conical anal retractor |
| 08033638800133 - Retractor | 2023-11-17 The Beak Surgical proctoscope |
| 08033638800157 - Retractor | 2023-11-17 The Beak Diagnostic |