| Primary Device ID | 08033638800621 |
| NIH Device Record Key | 6a2a4bd0-0ae9-4484-b02b-4793c485d01d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Rectoscope equipment |
| Version Model Number | Rectoscope equipment with LED and insufflator |
| Catalog Number | A.4513LINS |
| 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 | true |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08033638800614 [Primary] |
| GS1 | 08033638800621 [Package] Contains: 08033638800614 Package: [20 Units] In Commercial Distribution |
| KDM | Sigmoidoscope, Rigid, Non-Electrical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-02-25 |
| Device Publish Date | 2025-02-17 |
| 08033638801567 | Non sterile and disposable equipment made of 250mm rectoscope, grip and insufflator. |
| 08033638800720 | Non sterile and disposable equipment made of 250mm rectoscope, grip, insufflator and built-in LE |
| 08033638801536 | Non-sterile and disposable rectoscope equipment of 12,5mm diameter with insufflator and built-in |
| 08033638800621 | Non-sterile and disposable rectoscope equipment of 17mm diameter with insufflator and built-in L |