iSnare 00711084

GUDID 10816765012748

The iSnare system–Lariat snare is used to inject various types of media and to grasp, dissect and transect tissue during gastrointestinal endoscopy procedures, and can be used with or without monopolar diathermic energy.

US Endoscopy

Endoscopic electrosurgical submucosal lift/resection set

• Primary Device ID: 10816765012748
• NIH Device Record Key: 5695a50d-b8ab-4f83-9e1b-7f2f1eb2f0dc
• Commercial Distribution Discontinuation: 2020-03-17
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: iSnare
• Version Model Number: 00711084
• Catalog Number: 00711084
• 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

Device Dimensions

• Needle Gauge: 25 Gauge
• Needle Gauge: 25 Gauge
• Needle Gauge: 25 Gauge
• Needle Gauge: 25 Gauge
• Needle Gauge: 25 Gauge
• Needle Gauge: 25 Gauge
• Needle Gauge: 25 Gauge
• Needle Gauge: 25 Gauge
• Needle Gauge: 25 Gauge
• Needle Gauge: 25 Gauge
• Needle Gauge: 25 Gauge
• Needle Gauge: 25 Gauge

Operating and Storage Conditions

• Handling Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816765012741 [Primary]
GS1	10816765012748 [Package]; Contains: 00816765012741; Package: Box [5 Units]; Discontinued: 2020-03-17; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152035

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: Update
• Device Record Status: Published
• Public Version Number: 8
• Public Version Date: 2020-03-17
• Device Publish Date: 2017-02-24

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