| Primary Device ID | 00850261006200 |
| NIH Device Record Key | 8f30d20b-8640-418b-bb55-751b7542a889 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SmartBand EMR Pack |
| Version Model Number | SBEMRP94 |
| Catalog Number | SBEMRP94 |
| Company DUNS | 046601986 |
| Company Name | INTELLIGENT ENDOSCOPY LLC |
| 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 | true |
| 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 Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850261006200 [Primary] |
| FDI | SNARE, FLEXIBLE |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-03-29 |
| Device Publish Date | 2022-03-21 |
| 00850261006200 | SmartBand EMR Ligator Pack (9.4 mm) is indicated for endoscopic mucosal resection in the upper G |
| 00850261006118 | SmartBand EMR Ligator Pack (12mm) is indicated for endoscopic mucosal resection in the upper GI |
| 00850261006088 | SmartBand EMR Ligator Pack (10.75 mm) is indicated for endoscopic mucosal resection in the upper |