Insert, Round Nose Grasper ES0508

GUDID 10815288011276

ENCISION, INC.

Endoscopic electrosurgical electrode, monopolar, reusable

• Primary Device ID: 10815288011276
• NIH Device Record Key: d66c41ff-4f9b-431f-ad81-ea40bec617ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Insert, Round Nose Grasper
• Version Model Number: ES0508
• Catalog Number: ES0508
• 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	10815288011276 [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

[10815288011276]

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.

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• 10815288013812 - Fenestrated Bowel Grasper, 35cm, 20mm Jaw: 2024-02-08 Fenestrated Bowel Grasper, 35cm, 20mm Jaw
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• 10815288014253 - Rounded Maryland Dissector: 2023-06-29