| Primary Device ID | 10724995243750 |
| NIH Device Record Key | 8d05abcc-6c14-411e-8a79-e5a8bf81a160 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Exacto Mundo |
| Version Model Number | 00711078 |
| Catalog Number | 00711078 |
| Company DUNS | 627879687 |
| Company Name | US Endoscopy |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx | |
| Phone | +1(800)548-4873 |
| xx@xx.xx |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00724995243753 [Primary] |
| GS1 | 10724995243750 [Package] Contains: 00724995243753 Package: Box [20 Units] In Commercial Distribution |
| FGX | SNARE, NON-ELECTRICAL |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-08-27 |
| Device Publish Date | 2025-08-19 |
| 10724995243743 | The Exacto cold snare is intended to be used without diathermic energy for the endoscopic resect |
| 10724995243767 | The Exacto Mundo cold snare is intended to be used without diathermic energy for the endoscopic |
| 10724995243750 | The Exacto Mundo cold snare is intended to be used without diathermic energy for the endoscopic |