AEM enTouch 2X Scissor ES0201

GUDID 10815288013997

ENCISION, INC.

Endoscopic electrosurgical electrode, monopolar, reusable Endoscopic electrosurgical electrode, monopolar, reusable Endoscopic electrosurgical electrode, monopolar, reusable Endoscopic electrosurgical electrode, monopolar, reusable Endoscopic electrosurgical electrode, monopolar, reusable Endoscopic electrosurgical electrode, monopolar, reusable Endoscopic electrosurgical electrode, monopolar, reusable Endoscopic electrosurgical electrode, monopolar, reusable Endoscopic electrosurgical electrode, monopolar, reusable Endoscopic electrosurgical electrode, monopolar, reusable Endoscopic electrosurgical electrode, monopolar, reusable Endoscopic electrosurgical electrode, monopolar, reusable Endoscopic electrosurgical electrode, monopolar, reusable Endoscopic electrosurgical electrode, monopolar, reusable

• Primary Device ID: 10815288013997
• NIH Device Record Key: 48d4289f-ddac-4c3d-84f1-446a2a5e9124
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AEM enTouch 2X Scissor
• Version Model Number: ES0201
• Catalog Number: ES0201
• Company DUNS: 612250175
• Company Name: ENCISION, INC.
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Device Dimensions

• Length: 35 Centimeter
• Length: 35 Centimeter
• Length: 35 Centimeter
• Length: 35 Centimeter
• Length: 35 Centimeter
• Length: 35 Centimeter
• Length: 35 Centimeter
• Length: 35 Centimeter
• Length: 35 Centimeter
• Length: 35 Centimeter
• Length: 35 Centimeter
• Length: 35 Centimeter
• Length: 35 Centimeter
• Length: 35 Centimeter

Operating and Storage Conditions

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10815288013997 [Primary]
GS1	20815288013994 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201018

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

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: 2020-07-29
• Device Publish Date: 2020-07-21

On-Brand Devices [AEM enTouch 2X Scissor]

• 20815288014021: ES0202-45
• 20815288014014: ES0202
• 20815288014007: ES0201-45
• 10815288013997: ES0201