Smoke Evacuator Wand

GUDID 00817688021629

I.C. MEDICAL, INC.

Surgical plume evacuation system tube

• Primary Device ID: 00817688021629
• NIH Device Record Key: 51aa48ea-f242-4b1c-822a-9a02653ecac0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smoke Evacuator Wand
• Version Model Number: ICM-000-0075
• Company DUNS: 616182895
• Company Name: I.C. MEDICAL, 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: 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 Identifiers

Device Issuing Agency	Device ID
GS1	00817688021612 [Primary]
GS1	00817688021629 [Package]; Contains: 00817688021612; Package: [15 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K932230

FDA Product Code

• FYD: Apparatus, Exhaust, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-04-08
• Device Publish Date: 2016-09-24

On-Brand Devices [Smoke Evacuator Wand]

• 00817688021629: ICM-000-0075
• 00817688021605: ICM-000-0030
• 00817688022961: Smoke Evacuator Wand, Universal Connector, Sterile