| Primary Device ID | 00850261006040 | 
| NIH Device Record Key | e6d5ea42-df5a-494a-a690-acb3f60359e6 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | SmartBand SafeGrip Multi-Band Ligation Pack | 
| Version Model Number | SLP-6-LF | 
| Catalog Number | IE11003 | 
| Company DUNS | 046601986 | 
| Company Name | INTELLIGENT ENDOSCOPY LLC | 
| 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 | 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 | 
| Phone | +1(336)608-4375 | 
| info@intelligentendoscopy.com | |
| Phone | +1(336)608-4375 | 
| info@intelligentendoscopy.com | |
| Phone | +1(336)608-4375 | 
| info@intelligentendoscopy.com | |
| Phone | +1(336)608-4375 | 
| info@intelligentendoscopy.com | |
| Phone | +1(336)608-4375 | 
| info@intelligentendoscopy.com | |
| Phone | +1(336)608-4375 | 
| info@intelligentendoscopy.com | |
| Phone | +1(336)608-4375 | 
| info@intelligentendoscopy.com | |
| Phone | +1(336)608-4375 | 
| info@intelligentendoscopy.com | |
| Phone | +1(336)608-4375 | 
| info@intelligentendoscopy.com | |
| Phone | +1(336)608-4375 | 
| info@intelligentendoscopy.com | |
| Phone | +1(336)608-4375 | 
| info@intelligentendoscopy.com | |
| Phone | +1(336)608-4375 | 
| info@intelligentendoscopy.com | |
| Phone | +1(336)608-4375 | 
| info@intelligentendoscopy.com | |
| Phone | +1(336)608-4375 | 
| info@intelligentendoscopy.com | |
| Phone | +1(336)608-4375 | 
| info@intelligentendoscopy.com | |
| Phone | +1(336)608-4375 | 
| info@intelligentendoscopy.com | |
| Phone | +1(336)608-4375 | 
| info@intelligentendoscopy.com | 
| Width | 5.063 Inch | 
| Width | 5.063 Inch | 
| Width | 5.063 Inch | 
| Width | 5.063 Inch | 
| Depth | 0.625 Inch | 
| Weight | 0.05 Pound | 
| Height | 8 Inch | 
| Width | 5.063 Inch | 
| Depth | 0.625 Inch | 
| Weight | 0.05 Pound | 
| Height | 8 Inch | 
| Width | 5.063 Inch | 
| Depth | 0.625 Inch | 
| Weight | 0.05 Pound | 
| Height | 8 Inch | 
| Width | 5.063 Inch | 
| Depth | 0.625 Inch | 
| Weight | 0.05 Pound | 
| Height | 8 Inch | 
| Width | 5.063 Inch | 
| Depth | 0.625 Inch | 
| Weight | 0.05 Pound | 
| Height | 8 Inch | 
| Width | 5.063 Inch | 
| Depth | 0.625 Inch | 
| Weight | 0.05 Pound | 
| Height | 8 Inch | 
| Width | 5.063 Inch | 
| Depth | 0.625 Inch | 
| Weight | 0.05 Pound | 
| Height | 8 Inch | 
| Width | 5.063 Inch | 
| Depth | 0.625 Inch | 
| Weight | 0.05 Pound | 
| Height | 8 Inch | 
| Width | 5.063 Inch | 
| Depth | 0.625 Inch | 
| Weight | 0.05 Pound | 
| Height | 8 Inch | 
| Width | 5.063 Inch | 
| Depth | 0.625 Inch | 
| Weight | 0.05 Pound | 
| Height | 8 Inch | 
| Width | 5.063 Inch | 
| Depth | 0.625 Inch | 
| Weight | 0.05 Pound | 
| Height | 8 Inch | 
| Width | 5.063 Inch | 
| Depth | 0.625 Inch | 
| Weight | 0.05 Pound | 
| Height | 8 Inch | 
| Width | 5.063 Inch | 
| Depth | 0.625 Inch | 
| Weight | 0.05 Pound | 
| Height | 8 Inch | 
| Width | 5.063 Inch | 
| Depth | 0.625 Inch | 
| Weight | 0.05 Pound | 
| Height | 8 Inch | 
| Width | 5.063 Inch | 
| Depth | 0.625 Inch | 
| Weight | 0.05 Pound | 
| Height | 8 Inch | 
| Width | 5.063 Inch | 
| Depth | 0.625 Inch | 
| Weight | 0.05 Pound | 
| Height | 8 Inch | 
| Width | 5.063 Inch | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00850261006040 [Primary] | 
| MND | Ligator, esophageal | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 2 | 
| Public Version Date | 2018-03-29 | 
| Device Publish Date | 2017-08-01 | 
| 00850261006071 - SmartBand EMR Kit | 2022-03-29 SmartBand EMR Kit (10.75mm) is indicated for endoscopic mucosal resection in the upper GI tract. | 
| 00850261006088 - SmartBand EMR Pack | 2022-03-29 SmartBand EMR Ligator Pack (10.75 mm) is indicated for endoscopic mucosal resection in the upper GI tract and offers a reloadabl | 
| 00850261006101 - SmartBand EMR Kit | 2022-03-29 SmartBand EMR Kit (12mm) is indicated for endoscopic mucosal resection in the upper GI tract. | 
| 00850261006118 - SmartBand EMR Pack | 2022-03-29 SmartBand EMR Ligator Pack (12mm) is indicated for endoscopic mucosal resection in the upper GI tract and offers a reloadable b | 
| 00850261006125 - SmartSnare EMR Hexagonal Snare | 2022-03-29 SmartSnare EMR Hexagonal Snare supports resection of target pseudopolyp with its ultra-slim snare wire diameter and controlled r | 
| 00850261006200 - SmartBand EMR Pack | 2022-03-29 SmartBand EMR Ligator Pack (9.4 mm) is indicated for endoscopic mucosal resection in the upper GI tract and offers a reloadable | 
| 00850261006217 - SmartBand EMR Kit | 2022-03-29 The SmartBand EMR Kit (9.4mm) is indicated for endoscopic mucosal resection in the upper GI tract. | 
| 00850261006002 - SmartBand Ligation Pack | 2018-03-29 Multi-Band Ligation Pack |