PenEvac1

GUDID 00817688020097

I.C. MEDICAL, INC.

Open-surgery electrosurgical handpiece/electrode, monopolar, single-use

• Primary Device ID: 00817688020097
• NIH Device Record Key: c7e211d0-79a2-4562-a85f-7c8b51d213dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PenEvac1
• Version Model Number: ICM-000-0458
• Company DUNS: 616182895
• Company Name: I.C. MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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	00817688020080 [Primary]
GS1	00817688020097 [Package]; Contains: 00817688020080; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K954088

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-04-08
• Device Publish Date: 2016-09-24

On-Brand Devices [PenEvac1]

• 00817688022459: ICM-000-0562
• 00817688022176: ICM-000-0554
• 00817688022152: ICM-000-0552
• 00817688022053: ICM-000-0548
• 00817688022046: ICM-000-0547
• 00817688022039: ICM-000-0545
• 00817688022015: ICM-000-0541
• 00817688021926: ICM-000-0502
• 00817688021919: ICM-000-0497
• 00817688020479: ICM-000-0506
• 00817688020455: ICM-000-0500
• 00817688020431: ICM-000-0498
• 00817688020394: ICM-000-0494
• 00817688020370: ICM-000-0492
• 00817688020271: ICM-000-0478
• 00817688020257: ICM-000-0476
• 00817688020233: ICM-000-0474
• 00817688020219: ICM-000-0472
• 00817688020196: ICM-000-0470
• 00817688020172: ICM-000-0468
• 00817688020158: ICM-000-0466
• 00817688020134: ICM-000-0464
• 00817688020110: ICM-000-0462
• 00817688020097: ICM-000-0458
• 00817688020073: ICM-000-0456
• 00817688020059: ICM-000-0454
• 00817688020028: ICM-000-0450
• 00817688020004: ICM-000-0452
• 00817688022558: ICM-000-0574
• 00817688022534: ICM-000-0572
• 00817688022510: ICM-000-0570
• 00817688022633: ICM-000-0596
• 00817688022770: PenEvac1®, Non-Stick Blade, 10’ Tube, Universal Connector, Non-Sterile, Bulk
• 00817688022756: PenEvac1®, Stainless Steel Blade, 10’ Tube, Universal Connector, Non-Sterile, Bulk
• 00817688022732: PenEvac1®, Stainless Steel Blade, 10’ Tube, 22 mm to 10 mm Flexible Connector, Non-Sterile, B
• 00817688022671: PenEvac1®, Non-Stick Blade, 10’ Tube, 22 mm to 10 mm Flexible Connector, Non-Sterile, Bulk
• 00817688022879: PenEvac1®, Megadyne E-Z Clean Blade, 10’ Tube, Universal Connector, Non-Sterile, Bulk
• 00817688022855: PenEvac1®, Megadyne E-Z Clean Blade, 10’ Tube, 22mm to 10mm Flexible Connector, Non-Sterile,
• 00817688023876: PenEvac1®, Non-Stick ENT Needle, 10 Foot Tube, Universal Connector & Holster, Sterile
• 00817688023852: PenEvac1®, Stainless Steel ENT Needle, 10 Foot Tube, Universal Connector & Holster, Sterile
• 00817688023937: PenEvac1, Non-Stick Blade, 14-Foot Tube, 15-Foot Cable, Universal Connector & Holster, Sterile
• 00817688024132: PenEvac1®-NB, No Blade, 10 Foot Tube, Universal Connector & Holster, Sterile