SmartSnare EMR Hexagonal Snare SS2301

GUDID 00850261006125

SmartSnare EMR Hexagonal Snare supports resection of target pseudopolyp with its ultra-slim snare wire diameter and controlled rotation designed to facilitate placement around the band.

INTELLIGENT ENDOSCOPY LLC

Mechanical-cutting endoscopic polypectomy snare

• Primary Device ID: 00850261006125
• NIH Device Record Key: d6b28379-bbeb-4b6a-8a3e-9fb385a6c86b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartSnare EMR Hexagonal Snare
• Version Model Number: SS-230-1
• Catalog Number: SS2301
• 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

Customer Support Contacts

• Phone: +1(336)608-4375
• Email: info@intelligentendoscopy.com
• Phone: +1(336)608-4375
• Email: info@intelligentendoscopy.com
• Phone: +1(336)608-4375
• Email: info@intelligentendoscopy.com
• Phone: +1(336)608-4375
• Email: info@intelligentendoscopy.com
• Phone: +1(336)608-4375
• Email: info@intelligentendoscopy.com
• Phone: +1(336)608-4375
• Email: info@intelligentendoscopy.com
• Phone: +1(336)608-4375
• Email: info@intelligentendoscopy.com
• Phone: +1(336)608-4375
• Email: info@intelligentendoscopy.com
• Phone: +1(336)608-4375
• Email: info@intelligentendoscopy.com
• Phone: +1(336)608-4375
• Email: info@intelligentendoscopy.com
• Phone: +1(336)608-4375
• Email: info@intelligentendoscopy.com
• Phone: +1(336)608-4375
• Email: info@intelligentendoscopy.com

Device Dimensions

• Length: 230 Centimeter
• Width: 15 Millimeter
• Length: 230 Centimeter
• Width: 15 Millimeter
• Length: 230 Centimeter
• Width: 15 Millimeter
• Length: 230 Centimeter
• Width: 15 Millimeter
• Length: 230 Centimeter
• Width: 15 Millimeter
• Length: 230 Centimeter
• Width: 15 Millimeter
• Length: 230 Centimeter
• Width: 15 Millimeter
• Length: 230 Centimeter
• Width: 15 Millimeter
• Length: 230 Centimeter
• Width: 15 Millimeter
• Length: 230 Centimeter
• Width: 15 Millimeter
• Length: 230 Centimeter
• Width: 15 Millimeter
• Length: 230 Centimeter
• Width: 15 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850261006125 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212860

FDA Product Code

• FDI: SNARE, FLEXIBLE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-29
• Device Publish Date: 2022-03-21

Devices Manufactured by INTELLIGENT ENDOSCOPY LLC

• 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: 2022-03-29SmartSnare EMR Hexagonal Snare supports resection of target pseudopolyp with its ultra-slim snare wire diameter and controlled rotation designed to facilitate placement around the band.
• 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