PenEvac1 ICM-000-0504
GUDID 00817688024132
PenEvac1®-NB, No Blade, 10 Foot Tube, Universal Connector & Holster, Sterile
I.C. MEDICAL, INC.
Open-surgery electrosurgical handpiece/electrode, monopolar, single-use| Primary Device ID | 00817688024132 |
| NIH Device Record Key | e6151220-7f21-4a3d-bded-14c94db2ae64 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PenEvac1 |
| Version Model Number | ICM-000-0504 |
| Catalog Number | ICM-000-0504 |
| 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 |
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 | 00817688024125 [Primary] |
| GS1 | 00817688024132 [Package] Contains: 00817688024125 Package: [20 Units] In Commercial Distribution |
FDA Product Code
| GEI | Electrosurgical, Cutting & Coagulation & Accessories |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-25 |
| Device Publish Date | 2023-08-17 |
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 |
Trademark Results [PenEvac1]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PENEVAC1 85528850 4339601 Live/Registered |
I.C. Medical, Inc. 2012-01-30 |
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