SURG-E-VAC SMOKE EVACUATION SYSTEM SVF1

GUDID 00841494106799

QUAD FILTER FOR SVD 7/8" DIAMETER

Ellman International

Surgical plume evacuation system filter

• Primary Device ID: 00841494106799
• NIH Device Record Key: 4ec0c5e0-0e99-4eff-9747-2c4d1ebd790e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SURG-E-VAC SMOKE EVACUATION SYSTEM
• Version Model Number: SVF1
• Catalog Number: SVF1
• Company DUNS: 079095245
• Company Name: Ellman International
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841494106799 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K983333

FDA Product Code

• FYD: APPARATUS, EXHAUST, SURGICAL

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-21

On-Brand Devices [SURG-E-VAC SMOKE EVACUATION SYSTEM]

• 00841494106799: QUAD FILTER FOR SVD 7/8" DIAMETER
• 00841494104856: SURG-E-VAC 220V SMOKE EVACUATION SYSTEM
• 00841494104849: SURG-E-VAC 110V SMOKE EVACUATION SYSTEM