| Primary Device ID | 08033638800256 |
| NIH Device Record Key | 1670a232-c529-430a-b8d6-c2720082db19 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Rectoscope |
| Version Model Number | A.4519 |
| Catalog Number | A.4519 |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08033638800249 [Primary] |
| GS1 | 08033638800256 [Package] Contains: 08033638800249 Package: [12 Units] In Commercial Distribution |
| KDM | Sigmoidoscope, Rigid, Non-Electrical |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[08033638800256]
Ethylene Oxide
[08033638800256]
Ethylene Oxide
[08033638800256]
Ethylene Oxide
[08033638800256]
Ethylene Oxide
[08033638800256]
Ethylene Oxide
[08033638800256]
Ethylene Oxide
[08033638800256]
Ethylene Oxide
[08033638800256]
Ethylene Oxide
[08033638800256]
Ethylene Oxide
[08033638800256]
Ethylene Oxide
[08033638800256]
Ethylene Oxide
[08033638800256]
Ethylene Oxide
[08033638800256]
Ethylene Oxide
[08033638800256]
Ethylene Oxide
[08033638800256]
Ethylene Oxide
[08033638800256]
Ethylene Oxide
[08033638800256]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2023-11-17 |
| Device Publish Date | 2016-11-25 |
| 08033638800270 | Multi-purpose rectoscope |
| 08033638800256 | MPR short multi-purpose rectoscope |
| 08033638800218 | Rectoscope 250 mm |
| 08033638800195 | Pediatric rectoscope 200 mm |
| 08033638800171 | Proctoscope 130 mm |