SmartBand EMR Kit

Basic Information

• Brand Name: SmartBand EMR Kit
• Primary DI: 00850261006217
• Version / Model: SBEMRK94
• Catalog Number: SBEMRK94
• Company Name: INTELLIGENT ENDOSCOPY LLC
• Labeler DUNS: 046601986
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-03-21
• Public Version: 1
• Public Version Date: 2022-03-29
• Public Version Status: New
• Public Device Record Key: 62994800-925d-4bc7-8c90-2e4f3f766111

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FDI	SNARE, FLEXIBLE	Gastroenterology, Urology	876.4300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46680	Oesophageal endoscopic ligator, single-use	A device used in combination with a compatible flexible endoscope for the deployment of a rubber band to oesophageal varices during an endoscopic procedure which will create a haemostasis or necrosis of the varix. It is available in various designs and typically consists of a multiple band ligating unit that fits over the distal end of the endoscope with rubber latex ligating bands premounted on a band carrier, and controls that run along the outside of the endoscope terminating in a control handle at the proximal end that is used to deploy the bands as required. In some instances, this type of device could be used to treat haemorrhoids in the colon. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850261006217	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K212860	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			9.4 mm barrel tip diameter
Device Size Text, specify			EMR Hexagonal Snare Length 230cm
Device Size Text, specify			EMR Hexagonal Snare Width 15mm