Insert, Bowel Grasper ES0521

GUDID 10815288011450

ENCISION, INC.

Endoscopic electrosurgical electrode, monopolar, reusable

• Primary Device ID: 10815288011450
• NIH Device Record Key: 1f97a163-05bb-4278-9d01-cf39be417acf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Insert, Bowel Grasper
• Version Model Number: ES0521
• Catalog Number: ES0521
• 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: 35 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10815288011450 [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

[10815288011450]

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

On-Brand Devices [Insert, Bowel Grasper]

• 10815288011467: ES0521-45
• 10815288011450: ES0521