Insert, Tapered Right Angle Dissector ES0008

GUDID 10815288011030

ENCISION, INC.

Endoscopic electrosurgical electrode, monopolar, reusable

• Primary Device ID: 10815288011030
• NIH Device Record Key: 8a1681f0-e186-4bdc-80d7-aafc780ed6b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Insert, Tapered Right Angle Dissector
• Version Model Number: ES0008
• Catalog Number: ES0008
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	10815288011030 [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

[10815288011030]

Moist Heat or Steam Sterilization

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

Devices Manufactured by ENCISION, INC.

• 10815288014314 - Single Action Needle Holder, Ratcheting Handle, With Rotation, 35cm: 2024-02-15
• 10815288014345 - Round Tip Allis Grasping Forcep, Ratcheting Handle, With Rotation, 35cm: 2024-02-15
• 10815288011795 - 5mm Cobra Jaw Grasping Forcep, Ratcheting Handle, With Rotation: 2024-02-08
• 10815288013799 - Fenestrating Grasping Forcep, 35cm: 2024-02-08 Fenestrating Grasping Forcep, 35cm with Rotating/Ratcheting Handle
• 10815288013805 - Allis Forcep, 35cm: 2024-02-08 Allis Forcep, 35cm with Rotating/Ratcheting Handle
• 10815288013812 - Fenestrated Bowel Grasper, 35cm, 20mm Jaw: 2024-02-08 Fenestrated Bowel Grasper, 35cm, 20mm Jaw
• 10815288013829 - Traumatic Grasper, 35cm: 2024-02-08 Traumatic Grasper, 35cm with Rotating/Ratcheting Handle
• 10815288014253 - Rounded Maryland Dissector: 2023-06-29