PlumePen PLPRO4500

GUDID 00815198012236

Smoke Plume Electrosurgical Pencil, Non-stick blade

Buffalo Filter

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

• Primary Device ID: 00815198012236
• NIH Device Record Key: dba2c6bb-018f-4313-ada8-543ef9b282ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PlumePen
• Version Model Number: Pro
• Catalog Number: PLPRO4500
• Company DUNS: 787855907
• Company Name: Buffalo Filter
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 716-835-7000
• Email: bf.smoke.info@filtrationgroup.com
• Phone: 716-835-7000
• Email: bf.smoke.info@filtrationgroup.com
• Phone: 716-835-7000
• Email: bf.smoke.info@filtrationgroup.com
• Phone: 716-835-7000
• Email: bf.smoke.info@filtrationgroup.com
• Phone: 716-835-7000
• Email: bf.smoke.info@filtrationgroup.com
• Phone: 716-835-7000
• Email: bf.smoke.info@filtrationgroup.com
• Phone: 716-835-7000
• Email: bf.smoke.info@filtrationgroup.com
• Phone: 716-835-7000
• Email: bf.smoke.info@filtrationgroup.com
• Phone: 716-835-7000
• Email: bf.smoke.info@filtrationgroup.com
• Phone: 716-835-7000
• Email: bf.smoke.info@filtrationgroup.com
• Phone: 716-835-7000
• Email: bf.smoke.info@filtrationgroup.com
• Phone: 716-835-7000
• Email: bf.smoke.info@filtrationgroup.com
• Phone: 716-835-7000
• Email: bf.smoke.info@filtrationgroup.com
• Phone: 716-835-7000
• Email: bf.smoke.info@filtrationgroup.com
• Phone: 716-835-7000
• Email: bf.smoke.info@filtrationgroup.com
• Phone: 716-835-7000
• Email: bf.smoke.info@filtrationgroup.com
• Phone: 716-835-7000
• Email: bf.smoke.info@filtrationgroup.com
• Phone: 716-835-7000
• Email: bf.smoke.info@filtrationgroup.com

Device Dimensions

• Length: 15 Feet
• Length: 15 Feet
• Length: 15 Feet
• Length: 15 Feet
• Length: 15 Feet
• Length: 15 Feet
• Length: 15 Feet
• Length: 15 Feet
• Length: 15 Feet
• Length: 15 Feet
• Length: 15 Feet
• Length: 15 Feet
• Length: 15 Feet
• Length: 15 Feet
• Length: 15 Feet
• Length: 15 Feet
• Length: 15 Feet
• Length: 15 Feet

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815198012236 [Primary]
GS1	10815198012233 [Package]; Package: Box [2 Units]; In Commercial Distribution
GS1	20815198012230 [Package]; Package: Box [5 Units]; In Commercial Distribution
GS1	30815198012237 [Package]; Contains: 20815198012230; Package: Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103375

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-09-23

On-Brand Devices [PlumePen]

• 20815198012605: Disposable Capture Port Tip for Smoke Plume Electrosurgical Pencil
• 20815198012476: Disposable Capture Port Tip for Smoke Plume Electrosurgical Pencil
• 20815198012469: Disposable Capture Port Tip for Smoke Plume Electrosurgical Pencil
• 00815198012236: Smoke Plume Electrosurgical Pencil, Non-stick blade
• 30815198012220: Smoke Plume Electrosurgical Pencil, Non-stick blade
• 30815198012114: Smoke Plume Electrosurgical Pencil, Non-stick blade
• 30815198012107: Smoke Plume Electrosurgical Pencil, Stainless Steel blade
• 30815198012091: Smoke Plume Electrosurgical Pencil, Non-stick blade
• 30815198012084: Smoke Plume Electrosurgical Pencil, Stainless steel blade