2210J

GUDID 00817688022350

ICM-000-0420

I.C. MEDICAL, INC.

Surgical plume evacuation system

• Primary Device ID: 00817688022350
• NIH Device Record Key: e4c6a009-595a-4972-86c4-f454ec7a1066
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 2210J
• Catalog Number: 2210J
• 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: 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	00817688021476 [Previous]
GS1	00817688022343 [Primary]
GS1	00817688022350 [Package]; Contains: 00817688022343; Package: [9 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: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-04-08
• Device Publish Date: 2017-09-15

Devices Manufactured by I.C. MEDICAL, INC.

• 00817688024347 - PenEvac1®-ST, MaxReveal™ Diamond Crystal Blade®: 2024-08-29 PenEvac1®-ST, MaxReveal™ Diamond Crystal Blade®, 70mm (2.75in) Non-Stick Blade, 10 Foot Tube, Universal Connector and Holste
• 00817688022947 - Speculum Tubing: 2024-05-03 Speculum Tubing, 22mm to 10mm Connector, Sterile
• 00817688022961 - Smoke Evacuator Wand: 2024-05-03 Smoke Evacuator Wand, Universal Connector, Sterile
• 00817688024293 - Non-Telescopic PenEvac® MaxReveal ™ Diamond Crystal®: 2023-10-25 Non-Telescopic PenEvac®-ST, MaxReveal ™ Diamond Crystal®, 70mm (2.75in) Non-Stick ENT Needle, 10 Foot Tube, Universal Connec
• 00817688024316 - Non-Telescopic PenEvac® MaxReveal ™ Diamond Crystal®: 2023-10-25 Non-Telescopic PenEvac®-ST, MaxReveal ™ Diamond Crystal®, 70mm (2.75in) Non-Stick ENT Needle, 10 Foot Tube, 22mm to 10mm to
• 00817688024330 - Non-Telescopic PenEvac® MaxReveal ™ Diamond Crystal®: 2023-10-25 Non-Telescopic PenEvac®-ST, MaxReveal ™ Diamond Crystal®, 70mm (2.75in) Non-Stick ENT Needle, 10 Foot Tube, 10mm to Filter C
• 00817688024163 - PenEvac1®, MaxReveal ™ Diamond Crystal®: 2023-10-20 PenEvac1®-ST, MaxReveal ™ Diamond Crystal®, 70 mm (2.75in) Non-Stick Blade, 10 Foot Tube, Universal Connector and Holster, S
• 00817688024194 - PenEvac1®, MaxReveal ™ Diamond Crystal®: 2023-10-20 PenEvac1®-ST, MaxReveal ™ Diamond Crystal®, 70mm (2.75in) Non-Stick Blade, 10 Foot Tube, 22mm to 10mm Connector and Holster