EM3 Bipolar Adapter, Standard BP9004+

GUDID 10815288014161

ENCISION, INC.

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• Primary Device ID: 10815288014161
• NIH Device Record Key: a23d0121-a3b3-42a3-b2f1-ae0f99478da8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EM3 Bipolar Adapter, Standard
• Version Model Number: BP9004+
• Catalog Number: BP9004+
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	10815288014161 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122383

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-08
• Device Publish Date: 2022-02-28

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