Insert, Fenestrated Bowel Grasper ES0574-45

GUDID 10815288013294

ENCISION, INC.

Endoscopic electrosurgical electrode, monopolar, reusable

• Primary Device ID: 10815288013294
• NIH Device Record Key: e4538f47-71ac-4084-80fc-260a380bb67c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Insert, Fenestrated Bowel Grasper
• Version Model Number: ES0574-45
• Catalog Number: ES0574-45
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10815288013294 [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

[10815288013294]

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: 2016-09-22

On-Brand Devices [Insert, Fenestrated Bowel Grasper]

• 10815288013294: ES0574-45
• 10815288013256: ES0574
• 10815288011481: ES0522-45
• 10815288011474: ES0522