| Primary Device ID | 08033638802878 |
| NIH Device Record Key | 4cc2ef7e-19c8-456a-af91-4b88d2425ecb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Self-light anoscopes |
| Version Model Number | Self-led-light diagnostic anoscope + Led light |
| Catalog Number | A.4018L |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08033638802861 [Primary] |
| GS1 | 08033638802878 [Package] Contains: 08033638802861 Package: [25 Units] In Commercial Distribution |
| FER | Anoscope And Accessories |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-16 |
| Device Publish Date | 2026-02-06 |
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| 08033638801260 | SELF-LED-LIGHT - Surgical/Examination trunk-end proctoscope with built-in LED light. Disposable. |
| 08033638803585 | SELF-LED-LIGHT - Surgical/Examination flute beaked proctoscope with built-in LED light. Disposab |
| 08033638800447 | SELF-LIGHT SCOPE - Surgical/Examination trunk ended proctoscope. Disposable. Tube length 79mm. |
| 08033638802878 | SELF-LED-LIGHT - Diagnostic/pediatric beveled proctoscope with built-in LED light. Disposable. T |