PenEvac1®-ST, MaxReveal™ Diamond Crystal Blade® ICM-000-0719
GUDID 00817688024347
PenEvac1®-ST, MaxReveal™ Diamond Crystal Blade®, 70mm (2.75in) Non-Stick Blade, 10 Foot Tube, Universal Connector and Holster, Non-Sterile, Bulk
I.C. MEDICAL, INC.
Open-surgery electrosurgical handpiece/electrode, monopolar, single-use| Primary Device ID | 00817688024347 |
| NIH Device Record Key | ce8ff776-825d-4c85-b099-ece4ba5728b3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PenEvac1®-ST, MaxReveal™ Diamond Crystal Blade® |
| Version Model Number | ICM-000-0719 |
| Catalog Number | ICM-000-0719 |
| Company DUNS | 616182895 |
| Company Name | I.C. MEDICAL, INC. |
| Device Count | 25 |
| 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 | 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 |
Customer Support Contacts
| Phone | 6237800700 |
| inquiry@icmedical.com | |
| Phone | 6237800700 |
| inquiry@icmedical.com | |
| Phone | 6237800700 |
| inquiry@icmedical.com | |
| Phone | 6237800700 |
| inquiry@icmedical.com | |
| Phone | 6237800700 |
| inquiry@icmedical.com | |
| Phone | 6237800700 |
| inquiry@icmedical.com | |
| Phone | 6237800700 |
| inquiry@icmedical.com | |
| Phone | 6237800700 |
| inquiry@icmedical.com | |
| Phone | 6237800700 |
| inquiry@icmedical.com | |
| Phone | 6237800700 |
| inquiry@icmedical.com | |
| Phone | 6237800700 |
| inquiry@icmedical.com | |
| Phone | 6237800700 |
| inquiry@icmedical.com | |
| Phone | 6237800700 |
| inquiry@icmedical.com | |
| Phone | 6237800700 |
| inquiry@icmedical.com | |
| Phone | 6237800700 |
| inquiry@icmedical.com | |
| Phone | 6237800700 |
| inquiry@icmedical.com | |
| Phone | 6237800700 |
| inquiry@icmedical.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00817688024347 [Unit of Use] |
| GS1 | 00817688024354 [Primary] |
FDA Product Code
| GEI | Electrosurgical, Cutting & Coagulation & Accessories |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00817688024347]
Ethylene Oxide
[00817688024347]
Ethylene Oxide
[00817688024347]
Ethylene Oxide
[00817688024347]
Ethylene Oxide
[00817688024347]
Ethylene Oxide
[00817688024347]
Ethylene Oxide
[00817688024347]
Ethylene Oxide
[00817688024347]
Ethylene Oxide
[00817688024347]
Ethylene Oxide
[00817688024347]
Ethylene Oxide
[00817688024347]
Ethylene Oxide
[00817688024347]
Ethylene Oxide
[00817688024347]
Ethylene Oxide
[00817688024347]
Ethylene Oxide
[00817688024347]
Ethylene Oxide
[00817688024347]
Ethylene Oxide
[00817688024347]
Ethylene Oxide
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-29 |
| Device Publish Date | 2024-08-21 |
Devices Manufactured by I.C. MEDICAL, INC.
| 00817688024347 - PenEvac1®-ST, MaxReveal™ Diamond Crystal Blade® | 2024-08-29PenEvac1®-ST, MaxReveal™ Diamond Crystal Blade®, 70mm (2.75in) Non-Stick Blade, 10 Foot Tube, Universal Connector and Holster, Non-Sterile, Bulk |
| 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 |
Trademark Results [PenEvac1]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PENEVAC1 85528850 4339601 Live/Registered |
I.C. Medical, Inc. 2012-01-30 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.