Disposable Sheath ES0150A

GUDID 20815288010672

ENCISION, INC.

Electrosurgical system monitor/shield

• Primary Device ID: 20815288010672
• NIH Device Record Key: 0e4814d9-d8fd-431d-84b0-5a68d407b387
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Sheath
• Version Model Number: ES0150A
• Catalog Number: ES0150A
• 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: 35 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10815288010675 [Primary]
GS1	20815288010672 [Package]; Contains: 10815288010675; 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