2210J

GUDID 00817688022350

ICM-000-0420

I.C. MEDICAL, INC.

Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system Surgical plume evacuation system 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.

• 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
• 00817688024217 - PenEvac1®, MaxReveal ™ Diamond Crystal®: 2023-10-20 PenEvac1®-ST, MaxReveal ™ Diamond Crystal®, 70mm (2.75in) Non-Stick Blade, 10 Foot Tube, 10mm to Filter Connector and Holst