Diagnostic Medical

GUDID G373DM20120

20 x 12 mm Loop

Zinnanti Surgical Design Group Inc

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

• Primary Device ID: G373DM20120
• NIH Device Record Key: d0f2ec1b-cc8e-4638-92ef-6ce3e9e1b84b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Diagnostic Medical
• Version Model Number: DM2012
• Company DUNS: 078579514
• Company Name: Zinnanti Surgical Design Group 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: true
• 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
HIBCC	G373DM20120 [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: 2022-11-29
• Device Publish Date: 2022-11-21

Devices Manufactured by Zinnanti Surgical Design Group Inc

• G3731415120 - Zinnanti Surgical: 2024-02-05 6" Smoke Evac Fusion 15mm x 12mm Loop
• G373141002P0 - Zinnanti Surgical: 2024-02-02 2" Smoke Evac Fusion Preferred Blade
• G373141002PA0 - Zinnanti Surgical: 2024-02-02 2" Smoke Evac Fusion Plastics Blade
• G373DM15120 - Diagnostic Medical: 2023-12-15 15mm x 12mm Loop
• G3731400050 - Zinnanti Surgical: 2023-12-06 6" Smoke Evac Fusion 5mm Ball
• G3731420200 - Zinnanti Surgical: 2023-12-06 6" Smoke Evac Fusion 20mm 20mm Loop
• G3731410160 - Zinnanti Surgical: 2023-11-14 6" Smoke Evac Fusion Needle Tip
• G373141023DS0 - Zinnanti Surgical: 2023-09-15 2" Smoke-Evac Fusion Derm Tip Sharp