iSnare 00711086

GUDID 10724995180802

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

US Endoscopy

Endoscopic electrosurgical submucosal lift/resection set

• Primary Device ID: 10724995180802
• NIH Device Record Key: 1c1368bd-9a9a-4ac3-852d-f8f73c379aa2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iSnare
• Version Model Number: 00711086
• Catalog Number: 00711086
• Company DUNS: 627879687
• Company Name: US Endoscopy
• 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: false
• 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(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx

Device Dimensions

• Needle Gauge: 25 Gauge
• Length: 230 Centimeter
• Width: 2.5 Millimeter
• Needle Gauge: 25 Gauge
• Length: 230 Centimeter
• Width: 2.5 Millimeter
• Needle Gauge: 25 Gauge
• Length: 230 Centimeter
• Width: 2.5 Millimeter
• Needle Gauge: 25 Gauge
• Length: 230 Centimeter
• Width: 2.5 Millimeter
• Needle Gauge: 25 Gauge

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00724995180805 [Primary]
GS1	00816765010921 [Previous]
GS1	10724995180802 [Package]; Contains: 00724995180805; Package: Case [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040961

FDA Product Code

• FBK: endoscopic injection needle, gastroenterology-urology

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-27
• Device Publish Date: 2020-03-19

On-Brand Devices [iSnare]

• 10816765012748: The iSnare system–Lariat snare is used to inject various types of media and to grasp, dissect
• 10816765010942: The iSnare hexagonal system is a dual lumen device providing both needle injection and monopolar
• 10816765010935: The iSnare hexagonal system is a dual lumen device providing both needle injection and monopolar
• 10816765010928: The iSnare oval system is a dual lumen device providing both needle injection and monopolar elec
• 10816765010911: The iSnare system is a dual lumen device providing both needle injection and monopolar electroca
• 10724995180826: The iSnare hexagonal system is a dual lumen device providing both needle injection and monopolar
• 10724995180819: The iSnare hexagonal system is a dual lumen device providing both needle injection and monopolar
• 10724995180802: The iSnare oval system is a dual lumen device providing both needle injection and monopolar elec
• 10724995180796: The iSnare system is a dual lumen device providing both needle injection and monopolar electroca
• 10724995180789: The iSnare system–Lariat snare is used to inject various types of media and to grasp, dissect