MediSourceNet, Inc

GUDID 10850034735051

REGLI - Regular Non-Extendable Smoke Evacuation Pencil, Insulated Non-stick Ceramic Coated Blade, Holster, 10' Hose (1pc)

Medisourcenet, Inc

Open-surgery electrosurgical handpiece/electrode, monopolar, reusable

• Primary Device ID: 10850034735051
• NIH Device Record Key: ca03c435-5d16-4921-adee-0eb1c8bdca03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MediSourceNet, Inc
• Version Model Number: REGLI
• Company DUNS: 118269952
• Company Name: Medisourcenet, 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850034735054 [Primary]
GS1	10850034735051 [Package]; Contains: 00850034735054; Package: Master Case [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092732

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: 2021-09-07
• Device Publish Date: 2021-08-30

On-Brand Devices [MediSourceNet, Inc]

• 10850034735136: WELF-5 : WelFit Adaptor for ESU Pencils and Hyfrecators, 15' hose (1pc)
• 10850034735129: WELF - WelFit Adaptor for ESU Pencils and Hyfrecators, 10' hose (1pc)
• 10850034735112: EXTLI-5 : Extendable Smoke Evacuation Pencil, Insulated Non-stick Ceramic Coated Blade, Holster,
• 10850034735105: EXTL-5 : Extendable Smoke Evacuation Pencil, Non-stick Ceramic Coated Blade, Holster, 15' Hose (
• 10850034735099: EXTLI - Extendable Smoke Evacuation Pencil, Insulated Non-stick Ceramic Coated Blade, Holster,
• 10850034735082: EXTL - Extendable Smoke Evacuation Pencil, Non-stick Ceramic Coated Blade, Holster, 10' Hose (1p
• 10850034735075: REGL-5 : Regular Non-Extendable Smoke Evacuation Pencil, Non-stick Ceramic Coated Blade, Holster
• 10850034735068: REGLI-5 : Regular Non-Extendable Smoke Evacuation Pencil, Insulated Non-stick Ceramic Coated Bla
• 10850034735051: REGLI - Regular Non-Extendable Smoke Evacuation Pencil, Insulated Non-stick Ceramic Coated Blade
• 10850034735044: REGL - Regular Non-Extendable Smoke Evacuation Pencil, Non-stick Ceramic Coated Blade, Holster,
• 00850034735030: KWV-LT : KwikVac Liquid Trap / 20pcs in one box
• 00850034735023: KWV-F : KwikVac Smoke Evacuation Filter / 1 each
• 00850034735016: KWV-DT : KwikVac Detecto, Automatic Activation Device / 1 each
• 00850034735009: KWV-M : KwikVac Smoke Evacuation Unit - Each / 1 per Box / Smoke Evacuation Unit (1pc)
• 10850034735150: ESU Grounding Pad (1pack / 25 pack per Box / 8 Box per Case)
• 00850034735146: P9552F-MSN ESU Grounding Pad (1 pack / 25 pack per Box / 8 Box per Case)
• 00850034735160: KWV-StarterKit, Smoke Evacuation starter Kit. Includes Smoke Evacaution unit, Filter and Detecto