| Primary Device ID | 00853719006050 |
| NIH Device Record Key | c55d9bb8-3fa9-47e2-9dc5-d8b49380034b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Certus® 140 |
| Version Model Number | 2.45 GHz Ablation System |
| Catalog Number | LK20cm - 17ga |
| Company DUNS | 809758878 |
| Company Name | NEUWAVE 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com | |
| Phone | +1(877)323-9283 |
| info@neuwave.com |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -40 Degrees Celsius and 55 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00853719006050 [Primary] |
| NEY | SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00853719006050]
Ethylene Oxide
[00853719006050]
Ethylene Oxide
[00853719006050]
Ethylene Oxide
[00853719006050]
Ethylene Oxide
[00853719006050]
Ethylene Oxide
[00853719006050]
Ethylene Oxide
[00853719006050]
Ethylene Oxide
[00853719006050]
Ethylene Oxide
[00853719006050]
Ethylene Oxide
[00853719006050]
Ethylene Oxide
[00853719006050]
Ethylene Oxide
[00853719006050]
Ethylene Oxide
[00853719006050]
Ethylene Oxide
[00853719006050]
Ethylene Oxide
[00853719006050]
Ethylene Oxide
[00853719006050]
Ethylene Oxide
[00853719006050]
Ethylene Oxide
[00853719006050]
Ethylene Oxide
[00853719006050]
Ethylene Oxide
[00853719006050]
Ethylene Oxide
[00853719006050]
Ethylene Oxide
[00853719006050]
Ethylene Oxide
[00853719006050]
Ethylene Oxide
[00853719006050]
Ethylene Oxide
[00853719006050]
Ethylene Oxide
[00853719006050]
Ethylene Oxide
[00853719006050]
Ethylene Oxide
[00853719006050]
Ethylene Oxide
[00853719006050]
Ethylene Oxide
[00853719006050]
Ethylene Oxide
[00853719006050]
Ethylene Oxide
[00853719006050]
Ethylene Oxide
[00853719006050]
Ethylene Oxide
[00853719006050]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-01-09 |
| Device Publish Date | 2016-09-18 |
| 00853719006234 | Surgical Dual Probe Kit |
| 00853719006227 | Footswitch, 3M, Gen2 |
| 00853719006210 | Footswitch, 4M, Gen1 |
| 00853719006180 | Certus 140 2.45GHz Ablation System, with Ablation Confirmation, 120 VAC |
| 00853719006166 | Certus 140 2.45GHz Ablation System, 120 VAC |
| 00853719006159 | Dual Probe Clip, 17 Gauge |
| 00853719006142 | Dual Probe Clip, 17 Gauge, 5 Pack |
| 00853719006135 | SR25cm-13ga CertusSR Ablation Probe, 25 cm, 13 ga |
| 00853719006128 | CertuSurgGT CertuSurgGT Surgical Tool, 6 cm, 17 ga |
| 00853719006104 | LN20cm-17ga CertusLN Ablation Probe, 20 cm, 17 ga |
| 00853719006081 | LN15cm-17ga CertusLN Ablation Probe, 15 cm, 17 ga |
| 00853719006074 | LK20cm-15ga CertusLK Ablation Probe, 20 cm, 15 ga |
| 00853719006067 | LK15cm-15ga CertusLK Ablation Probe, 15 cm, 15 ga |
| 00853719006050 | LK20cm-17ga CertusLK Ablation Probe, 20 cm, 17 ga |
| 00853719006043 | LK15cm-17ga CertusLK Ablation Probe, 15 cm, 17 ga |
| 00853719006036 | PR20cm-15ga CertusPR Ablation Probe, 20 cm, 15 ga |
| 00853719006029 | PR15cm-15ga CertusPR Ablation Probe, 15 cm, 15 ga |
| 00853719006012 | PR20cm-17ga CertusPR Ablation Probe, 20 cm, 17 ga |
| 00853719006005 | PR15cm-17ga CertusPR Ablation Probe, 15 cm, 17 ga |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CERTUS 98696417 not registered Live/Pending |
American Safety Council, Inc. 2024-08-13 |
![]() CERTUS 98696413 not registered Live/Pending |
American Safety Council, Inc. 2024-08-13 |
![]() CERTUS 98696405 not registered Live/Pending |
American Safety Council, Inc. 2024-08-13 |
![]() CERTUS 98199938 not registered Live/Pending |
Population Health Partners, L.P. 2023-09-27 |
![]() CERTUS 98023564 not registered Live/Pending |
American Safety Council, Inc. 2023-06-01 |
![]() CERTUS 97859208 not registered Live/Pending |
American Safety Council, Inc. 2023-03-27 |
![]() CERTUS 97665293 not registered Live/Pending |
American Safety Council, Inc. 2022-11-07 |
![]() CERTUS 90701137 not registered Live/Pending |
Integrity Implants, Inc. 2021-05-10 |
![]() CERTUS 90052711 not registered Live/Pending |
National Coatings & Supplies, Inc. 2020-07-14 |
![]() CERTUS 90052699 not registered Live/Pending |
National Coatings & Supplies, Inc. 2020-07-14 |
![]() CERTUS 90011153 not registered Live/Pending |
National Coatings & Supplies, Inc. 2020-06-19 |
![]() CERTUS 88873049 not registered Live/Pending |
Lattice Semiconductor Corporation 2020-04-15 |