Rounded Maryland Dissector ES0586-45

GUDID 10815288014260

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

• Primary Device ID: 10815288014260
• NIH Device Record Key: 963760df-6249-4940-85d2-33d84655eb53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rounded Maryland Dissector
• Version Model Number: ES0586-45
• Catalog Number: ES0586-45
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter
• Length: 45 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10815288014260 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191612

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

[10815288014260]

Moist Heat or Steam Sterilization

[10815288014260]

Moist Heat or Steam Sterilization

[10815288014260]

Moist Heat or Steam Sterilization

[10815288014260]

Moist Heat or Steam Sterilization

[10815288014260]

Moist Heat or Steam Sterilization

[10815288014260]

Moist Heat or Steam Sterilization

[10815288014260]

Moist Heat or Steam Sterilization

[10815288014260]

Moist Heat or Steam Sterilization

[10815288014260]

Moist Heat or Steam Sterilization

[10815288014260]

Moist Heat or Steam Sterilization

[10815288014260]

Moist Heat or Steam Sterilization

[10815288014260]

Moist Heat or Steam Sterilization

[10815288014260]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-29
• Device Publish Date: 2023-06-21

On-Brand Devices [Rounded Maryland Dissector]

• 10815288014260: ES0586-45
• 10815288014253: ES0586