Maxtown Medical

GUDID B4193683010

Bipolar Insulated Malis 1.0T Bay 8.75", Non-Stick

Modern Surgical Instruments LLC

Open-surgery electrosurgical handpiece/electrode, bipolar, reusable

• Primary Device ID: B4193683010
• NIH Device Record Key: f2043e14-932e-436a-bcfb-596e911a8268
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Maxtown Medical
• Version Model Number: 3-683-01
• Company DUNS: 118447158
• Company Name: Modern Surgical Instruments LLC
• 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: false
• Expiration Date: false
• 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	B4193683010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182773

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

[B4193683010]

Moist Heat or Steam Sterilization

[B4193683010]

Moist Heat or Steam Sterilization

[B4193683010]

Moist Heat or Steam Sterilization

[B4193683010]

Moist Heat or Steam Sterilization

[B4193683010]

Moist Heat or Steam Sterilization

[B4193683010]

Moist Heat or Steam Sterilization

[B4193683010]

Moist Heat or Steam Sterilization

[B4193683010]

Moist Heat or Steam Sterilization

[B4193683010]

Moist Heat or Steam Sterilization

[B4193683010]

Moist Heat or Steam Sterilization

[B4193683010]

Moist Heat or Steam Sterilization

[B4193683010]

Moist Heat or Steam Sterilization

[B4193683010]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-22
• Device Publish Date: 2025-08-14

On-Brand Devices [Maxtown Medical]

• B4193680040: 3-680-04
• B4193600010: 3-600-01
• B4193147010: 3-147-01
• B419344301080: Bipolar Insulated Scoville-Greenwood 1.5mm Tip Bayonet Non-Stick
• B4193360010: Bipolar Insulated Semkin Non-Stick .5mm Tip Straight 5"
• B4193123010: Bipolar Insulated Microtine 0.7Tip Bayonet 6.7"
• B4193611000: Bipolar Insulated Shepard .6mm Tip Angled 4.6"
• B4193636010: Bipolar Insulated Malis Non-Stick Silver Alloy 0.45mm Tips Straight 5"
• B4193418010: Bipolar Insulated Cushing Bayoneted Bipolar Forcep 1.2mm Tip Bayonet 7.5"
• B4193465010: Bipolar Insulated Non-Stick Yasargil 1mm Tip Bayonet 7.5"
• B419350801080: BP IN K-YASAR 1.3T BAY 7.88
• B4193683010: Bipolar Insulated Malis 1.0T Bay 8.75", Non-Stick