iSnare

Basic Information

• Brand Name: iSnare
• Primary DI: 00724995180805
• Version / Model: 00711086
• Catalog Number: 00711086
• Company Name: US Endoscopy
• Labeler DUNS: 627879687
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-19
• Public Version: 2
• Public Version Date: 2020-11-10
• Public Version Status: Update
• Public Device Record Key: 1c1368bd-9a9a-4ac3-852d-f8f73c379aa2

Device Description

The iSnare oval system is a dual lumen device providing both needle injection and monopolar electrocautery polypectomy snare capability within a single catheter device.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FBK	endoscopic injection needle, gastroenterology-urology	Gastroenterology, Urology	876.1500	2
FDI	SNARE, FLEXIBLE	Gastroenterology, Urology	876.4300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46632	Endoscopic electrosurgical submucosal lift/resection set	A collection of devices designed to be used during an endoscopic mucosal resection procedure to: 1) lift a section of diseased mucosa by injection of a submucosal lifting solution; and 2) resect the lesion using monopolar electrosurgical energy; it may in addition include devices designed to perform vacuum elevation of the lesion to supplement submucosal lifting. It includes a submucosal injection needle, an electrosurgical electrode (e.g., polyp snare), and might include additional supportive devices such as a dye spray catheter and endoscope suction cap. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10724995180802	GS1	Case	5	In Commercial Distribution
Primary	00724995180805	GS1
Previous	00816765010921	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	230	Centimeter
Width	2.5	Millimeter
Needle Gauge	25	Gauge

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry