FILTRESSE SSE-200

GUDID H671SSE2000

Smoke Filtration System (230 Volts AC)

UTAH MEDICAL PRODUCTS, INC.

Surgical plume evacuation system

• Primary Device ID: H671SSE2000
• NIH Device Record Key: 10cf0f12-b746-4e74-ac1b-39308e1ba5fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FILTRESSE
• Version Model Number: 230VAC
• Catalog Number: SSE-200
• Company DUNS: 094651270
• Company Name: UTAH MEDICAL PRODUCTS, 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
HIBCC	H671SSE2000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K952981

FDA Product Code

• FYD: Apparatus, Exhaust, Surgical

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: 2020-06-12
• Device Publish Date: 2020-06-04

On-Brand Devices [FILTRESSE]

• H671SSE1000: Smoke Filtration System (115 Volts AC)
• H671SSE2000: Smoke Filtration System (230 Volts AC)