Geiger Thermal Cautery Unit 150

GUDID 00609960001111

TCU, THERMAL CAUTERY, UNIT ONLY, 110v, Medical Device

DERMATOLOGIC LAB AND SUPPLY, INC.

Electrocautery system generator, line-powered

• Primary Device ID: 00609960001111
• NIH Device Record Key: 3b41f459-e6e6-4305-b682-1b85ba0e68b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Geiger Thermal Cautery Unit
• Version Model Number: 150
• Catalog Number: 150
• Company DUNS: 021628771
• Company Name: DERMATOLOGIC LAB AND SUPPLY, 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: false
• Lot Batch: false
• Serial Number: true
• 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
GS1	00609960001111 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002341

FDA Product Code

• HQO: Unit, Cautery, Thermal, Ac-Powered

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-08-10
• Device Publish Date: 2018-07-10

On-Brand Devices [Geiger Thermal Cautery Unit]

• 00609960001128: TCU, THERMAL CAUTERY, UNIT ONLY, 220v. Medical Device.
• 00609960001111: TCU, THERMAL CAUTERY, UNIT ONLY, 110v, Medical Device
• 00609960000817: THERMAL CAUTERY UNIT,GEIGER TCU w/THERMALITES,220v. Medical Device.
• 00609960000800: THERMAL CAUTERY UNIT,GEIGER TCU w/THERMALITES,110V. Medical Device.
• 00609960000794: THERMAL CAUTERY UNIT,GEIGER TCU,W/201 TIPS,220 VLT. Medical Device.
• 00609960000787: THERMAL CAUTERY UNIT,GEIGER TCU, W/201 TIPS, 110V. Medical Device.