SmartBand Ligation Pack IE11001

GUDID 00850261006002

Multi-Band Ligation Pack

INTELLIGENT ENDOSCOPY LLC

Oesophageal endoscopic ligator, single-use

• Primary Device ID: 00850261006002
• NIH Device Record Key: 2cdc020f-4e69-42fa-8ed1-c28531e969d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartBand Ligation Pack
• Version Model Number: SLP-6
• Catalog Number: IE11001
• 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: true
• Labeled No Natural Rubber Latex: false
• 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
• 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

• Height: 8 Inch
• Height: 8 Inch
• Height: 8 Inch
• Height: 8 Inch
• Depth: 0.625 Inch
• Width: 5.063 Inch
• Weight: 0.05 Pound
• Height: 8 Inch
• Depth: 0.625 Inch
• Width: 5.063 Inch
• Weight: 0.05 Pound
• Height: 8 Inch
• Depth: 0.625 Inch
• Width: 5.063 Inch
• Weight: 0.05 Pound
• Height: 8 Inch
• Depth: 0.625 Inch
• Width: 5.063 Inch
• Weight: 0.05 Pound
• Height: 8 Inch
• Depth: 0.625 Inch
• Width: 5.063 Inch
• Weight: 0.05 Pound
• Height: 8 Inch
• Depth: 0.625 Inch
• Width: 5.063 Inch
• Weight: 0.05 Pound
• Height: 8 Inch
• Depth: 0.625 Inch
• Width: 5.063 Inch
• Weight: 0.05 Pound
• Height: 8 Inch
• Depth: 0.625 Inch
• Width: 5.063 Inch
• Weight: 0.05 Pound
• Height: 8 Inch
• Depth: 0.625 Inch
• Width: 5.063 Inch
• Weight: 0.05 Pound
• Height: 8 Inch
• Depth: 0.625 Inch
• Width: 5.063 Inch
• Weight: 0.05 Pound
• Height: 8 Inch
• Depth: 0.625 Inch
• Width: 5.063 Inch
• Weight: 0.05 Pound
• Height: 8 Inch
• Depth: 0.625 Inch
• Width: 5.063 Inch
• Weight: 0.05 Pound
• Height: 8 Inch
• Depth: 0.625 Inch
• Width: 5.063 Inch
• Weight: 0.05 Pound
• Height: 8 Inch
• Depth: 0.625 Inch
• Width: 5.063 Inch
• Weight: 0.05 Pound
• Height: 8 Inch
• Depth: 0.625 Inch
• Width: 5.063 Inch
• Weight: 0.05 Pound
• Height: 8 Inch
• Depth: 0.625 Inch
• Width: 5.063 Inch
• Weight: 0.05 Pound
• Height: 8 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850261006002 [Primary]

FDA Product Code

• FHN: Ligator, hemorrhoidal

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-08-01

Devices Manufactured by INTELLIGENT ENDOSCOPY LLC

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• 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: 2018-03-29Multi-Band Ligation Pack
• 00850261006002 - SmartBand Ligation Pack: 2018-03-29 Multi-Band Ligation Pack