SmartBand EMR Kit SBEMRK94

GUDID 00850261006217

The SmartBand EMR Kit (9.4mm) is indicated for endoscopic mucosal resection in the upper GI tract.

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: 00850261006217
• NIH Device Record Key: 62994800-925d-4bc7-8c90-2e4f3f766111
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartBand EMR Kit
• Version Model Number: SBEMRK94
• Catalog Number: SBEMRK94
• 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00850261006217 [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 Kit]

• 00850261006217: The SmartBand EMR Kit (9.4mm) is indicated for endoscopic mucosal resection in the upper GI trac
• 00850261006101: SmartBand EMR Kit (12mm) is indicated for endoscopic mucosal resection in the upper GI tract.
• 00850261006071: SmartBand EMR Kit (10.75mm) is indicated for endoscopic mucosal resection in the upper GI tract