SmartBand EMR Pack SBEMRP

GUDID 00850261006088

SmartBand EMR Ligator Pack (10.75 mm) is indicated for endoscopic mucosal resection in the upper GI tract and offers a reloadable barrel of bands for procedures requiring more than 5 bands.

INTELLIGENT ENDOSCOPY LLC

Oesophageal endoscopic ligator, single-use Oesophageal endoscopic ligator, single-use Oesophageal endoscopic ligator, single-use Oesophageal endoscopic ligator, single-use Oesophageal endoscopic ligator, single-use Oesophageal endoscopic ligator, single-use Oesophageal endoscopic ligator, single-use Oesophageal endoscopic ligator, single-use Oesophageal endoscopic ligator, single-use Oesophageal endoscopic ligator, single-use Oesophageal endoscopic ligator, single-use Oesophageal endoscopic ligator, single-use

• Primary Device ID: 00850261006088
• NIH Device Record Key: ceb782b5-96d2-4c14-a71a-a26cff934b51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartBand EMR Pack
• Version Model Number: SBEMRP
• Catalog Number: SBEMRP
• 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

• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00850261006088 [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

On-Brand Devices [SmartBand EMR Pack]

• 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