AEM® Handle, Hooded ES8000H

GUDID 10815288010255

ENCISION, INC.

Electrosurgical handpiece, reusable

• Primary Device ID: 10815288010255
• NIH Device Record Key: 2bf3c9cd-bb75-4158-95d9-be0b182af1ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AEM® Handle, Hooded
• Version Model Number: ES8000H
• Catalog Number: ES8000H
• 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
• Length: 35 Centimeter
• Length: 35 Centimeter
• Length: 35 Centimeter
• Length: 35 Centimeter
• Length: 35 Centimeter
• Length: 35 Centimeter
• 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	10815288010255 [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

[10815288010255]

Moist Heat or Steam Sterilization

[10815288010255]

Moist Heat or Steam Sterilization

[10815288010255]

Moist Heat or Steam Sterilization

[10815288010255]

Moist Heat or Steam Sterilization

[10815288010255]

Moist Heat or Steam Sterilization

[10815288010255]

Moist Heat or Steam Sterilization

[10815288010255]

Moist Heat or Steam Sterilization

[10815288010255]

Moist Heat or Steam Sterilization

[10815288010255]

Moist Heat or Steam Sterilization

[10815288010255]

Moist Heat or Steam Sterilization

[10815288010255]

Moist Heat or Steam Sterilization

[10815288010255]

Moist Heat or Steam Sterilization

[10815288010255]

Moist Heat or Steam Sterilization

[10815288010255]

Moist Heat or Steam Sterilization

[10815288010255]

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

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