Disposable Sheath ES0150-45

GUDID 20815288010689

ENCISION, INC.

Electrosurgical system monitor/shield

• Primary Device ID: 20815288010689
• NIH Device Record Key: 2fe5925e-b382-4e4b-93c3-3e8b477862f2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Sheath
• Version Model Number: ES0150-45
• Catalog Number: ES0150-45
• 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: true
• 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: 45 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10815288010682 [Primary]
GS1	20815288010689 [Package]; Contains: 10815288010682; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191612

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-03-25
• Device Publish Date: 2016-08-31

On-Brand Devices [Disposable Sheath]

• 20815288010689: ES0150-45
• 20815288010672: ES0150A