AEM® Shield Disposable Electrode, Spatula FC0301+

GUDID 10815288014178

ENCISION, INC.

Endoscopic electrosurgical electrode, monopolar, single-use

• Primary Device ID: 10815288014178
• NIH Device Record Key: 629d14a9-8f42-4a75-84d3-49ff6248b6ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AEM® Shield Disposable Electrode, Spatula
• Version Model Number: FC0301+
• Catalog Number: FC0301+
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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
• Length: 35 Centimeter
• Length: 35 Centimeter
• Length: 35 Centimeter
• Length: 35 Centimeter
• Length: 35 Centimeter
• Length: 35 Centimeter
• Length: 35 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10815288014178 [Primary]
GS1	20815288014175 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-27
• Device Publish Date: 2022-06-17

On-Brand Devices [AEM® Shield Disposable Electrode, Spatula]

• 20815288014182: FC0301-45+
• 10815288014178: FC0301+