Bovie

GUDID 00821925008076

Disposable Sterile Non-Stick Blade Electrode (10/PK)

Gyrus Acmi, Inc.

Electrosurgical return electrode, single-use

• Primary Device ID: 00821925008076
• NIH Device Record Key: 13bd0c39-6d55-4d32-89a6-3ce1adac3674
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bovie
• Version Model Number: 568601
• Company DUNS: 007198742
• Company Name: Gyrus Acmi, 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00821925008076 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K935947

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: 2024-08-02
• Device Publish Date: 2024-07-25

On-Brand Devices [Bovie]

• 00821925008458: Blade Electrode Non-Stick (10/PK)
• 00821925008083: Extended Blade Electrode 6” (15.24 cm) Non-Stick (10/PK)
• 00821925008076: Disposable Sterile Non-Stick Blade Electrode (10/PK)