GoldVac Slim 60-7670-001

GUDID 20815198012391

Push Button Smoke Evacuation Pencil, 15ft

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

• Primary Device ID: 20815198012391
• NIH Device Record Key: 9b0a8da5-d91e-413d-99ec-a86c9b8dfcc3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GoldVac Slim
• Version Model Number: 15ft
• Catalog Number: 60-7670-001
• 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

Device Dimensions

• Length: 10 Feet
• Length: 10 Feet
• Length: 10 Feet
• Length: 10 Feet
• Length: 10 Feet
• Length: 10 Feet
• Length: 10 Feet
• Length: 10 Feet
• Length: 10 Feet
• Length: 10 Feet
• Length: 10 Feet
• Length: 10 Feet
• Length: 10 Feet
• Length: 10 Feet
• Length: 10 Feet
• Length: 10 Feet
• Length: 10 Feet

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815198012397 [Primary]
GS1	10815198012394 [Package]; Contains: 00815198012397; Package: Box [5 Units]; In Commercial Distribution
GS1	20815198012391 [Package]; Contains: 10815198012394; Package: Box [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-23
• Device Publish Date: 2019-05-15

On-Brand Devices [GoldVac Slim]

• 20815198012391: Push Button Smoke Evacuation Pencil, 15ft
• 20815198012384: Push Button Smoke Evacuation Pencil