Electrode

GUDID 00817688021001

I.C. MEDICAL, INC.

Open-surgery electrosurgical handpiece/electrode, monopolar, single-use Open-surgery electrosurgical handpiece/electrode, monopolar, single-use

• Primary Device ID: 00817688021001
• NIH Device Record Key: 663992fd-9ae9-4428-9db4-481abdfc49c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Electrode
• Version Model Number: ICM-000-0330
• Company DUNS: 616182895
• Company Name: I.C. MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00817688020998 [Primary]
GS1	00817688021001 [Package]; Contains: 00817688020998; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K954088

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-04-08
• Device Publish Date: 2016-09-24

On-Brand Devices [Electrode]

• 00817688021049: ICM-000-0334
• 00817688021025: ICM-000-0332
• 00817688021001: ICM-000-0330
• 00817688020981: ICM-000-0251
• 00817688020967: ICM-000-0249
• 00817688020943: ICM-000-0245
• 00817688020929: ICM-000-0242
• 00817688020905: ICM-000-0215