Diagnostic Medical

GUDID G373DM10080

DM1008

Zinnanti Surgical Design Group Inc

Open-surgery electrosurgical electrode, monopolar, single-use

• Primary Device ID: G373DM10080
• NIH Device Record Key: 5cbb8fdb-0947-42e1-87b4-bfefb1c7c8bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Diagnostic Medical
• Version Model Number: DM1008
• 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	G373DM10080 [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

On-Brand Devices [Diagnostic Medical]

• G373DS10100: 10 x 10 mm Square
• G373DS10040: 10 x 4 mm Square
• G373DM20200: 20 x 20 mm Loop
• G373DM20150: 20 x 15 mm Loop
• G373DM20100: 20 x 10 mm Loop
• G373DM20080: 20 x 8 mm Loop
• G373DM15150: 15 x 15 mm Loop
• G373DM15100: 15 x 10 mm Loop
• G373DM15080: 15 x 8 mm Loop
• G373DM10100: 10 x 10 mm Loop
• G373DM10080: DM1008
• G373DM00500: 5 mm Ball Tip
• G373DM15120: 15mm x 12mm Loop