Non-Telescopic PenEvac

GUDID 00817688020615

I.C. MEDICAL, INC.

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

• Primary Device ID: 00817688020615
• NIH Device Record Key: 4cdcb328-6a9c-4993-8148-234830cf918a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Non-Telescopic PenEvac
• Version Model Number: ICM-000-0520
• 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	00817688020608 [Primary]
GS1	00817688020615 [Package]; Contains: 00817688020608; Package: [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160160

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 [Non-Telescopic PenEvac]

• 00817688022442: ICM-000-0564
• 00817688022213: ICM-000-0558
• 00817688022190: ICM-000-0556
• 00817688022077: ICM-000-0550
• 00817688022060: ICM-000-0549
• 00817688022022: ICM-000-0544
• 00817688022008: ICM-000-0540
• 00817688020783: ICM-000-0538
• 00817688020752: ICM-000-0536
• 00817688020745: ICM-000-0534
• 00817688020721: ICM-000-0532
• 00817688020707: ICM-000-0530
• 00817688020684: ICM-000-0528
• 00817688020660: ICM-000-0526
• 00817688020646: ICM-000-0524
• 00817688021803: ICM-000-0522
• 00817688020615: ICM-000-0520
• 00817688020592: ICM-000-0518
• 00817688020578: ICM-000-0516
• 00817688020554: ICM-000-0514
• 00817688020530: ICM-000-0512
• 00817688020516: ICM-000-0510
• 00817688020493: ICM-000-0508
• 00817688020417: ICM-000-0496
• 00817688022619: ICM-000-0580
• 00817688022596: ICM-000-0578
• 00817688022572: ICM-000-0576
• 00817688022831: Non-Telescopic PenEvac®, Non-Stick Blade, 10’ Tube, Universal Connector, Non-Sterile, Bulk
• 00817688022817: Non-Telescopic PenEvac®, Stainless Steel Blade, 10’ Tube, Universal Connector, Non-Sterile, B
• 00817688022794: Non-Telescopic PenEvac®, Stainless Steel Blade, 10’ Tube, 22 mm to 10 mm Flexible Connector,
• 00817688022718: Non-Telescopic PenEvac®, Non-Stick Blade, 10’ Tube, 22 mm to 10 mm Flexible Connector, Non-St
• 00817688022695: Non-Telescopic PenEvac®, Non-Stick Blade, 10’ Tube, Non-Sterile, Bulk
• 00817688022916: Non-Telescopic PenEvac®, Megadyne E-Z Clean Blade, 10’ Tube, Universal Connector, Non-Sterile
• 00817688022893: Non-Telescopic PenEvac®, Megadyne E-Z Clean Blade, 10’ Tube, 22 mm to 10 mm Flexible Connecto
• 00817688023913: Non-Telescopic PenEvac®, Non-Stick ENT Needle, 10 Foot Tube, Universal Connector & Holster, Ste
• 00817688023890: Non-Telescopic PenEvac®, Stainless Steel ENT Needle, 10 Foot Tube, Universal Connector & Holste
• 00817688024156: Non-Telescopic PenEvac®-NB , No Blade, 10 Foot Tube, Universal Connector & Holster, Sterile