Duoblade
GUDID 08809900940025
CnC Technologies
Electrosurgical handpiece, single-use| Primary Device ID | 08809900940025 |
| NIH Device Record Key | 4e13343b-0b01-4a51-9f9c-310d5d36589d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Duoblade |
| Version Model Number | DB1SEP-T |
| Company DUNS | 695063601 |
| Company Name | CnC Technologies |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| 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 |
Customer Support Contacts
| Phone | 619 356 0583 |
| jhegener@cresen.co | |
| Phone | 619 356 0583 |
| jhegener@cresen.co | |
| Phone | 619 356 0583 |
| jhegener@cresen.co | |
| Phone | 619 356 0583 |
| jhegener@cresen.co | |
| Phone | 619 356 0583 |
| jhegener@cresen.co | |
| Phone | 619 356 0583 |
| jhegener@cresen.co | |
| Phone | 619 356 0583 |
| jhegener@cresen.co | |
| Phone | 619 356 0583 |
| jhegener@cresen.co | |
| Phone | 619 356 0583 |
| jhegener@cresen.co | |
| Phone | 619 356 0583 |
| jhegener@cresen.co | |
| Phone | 619 356 0583 |
| jhegener@cresen.co | |
| Phone | 619 356 0583 |
| admin@cresen.co | |
| Phone | 619 356 0583 |
| admin@cresen.co | |
| Phone | 619 356 0583 |
| admin@cresen.co | |
| Phone | 619 356 0583 |
| admin@cresen.co | |
| Phone | 619 356 0583 |
| admin@cresen.co | |
| Phone | 619 356 0583 |
| admin@cresen.co | |
| Phone | 619 356 0583 |
| admin@cresen.co | |
| Phone | 619 356 0583 |
| admin@cresen.co | |
| Phone | 619 356 0583 |
| admin@cresen.co | |
| Phone | 619 356 0583 |
| admin@cresen.co | |
| Phone | 619 356 0583 |
| admin@cresen.co | |
| Phone | 619 356 0583 |
| admin@cresen.co | |
| Phone | 619 356 0583 |
| admin@cresen.co | |
| Phone | 619 356 0583 |
| admin@cresen.co | |
| Phone | 619 356 0583 |
| admin@cresen.co | |
| Phone | 619 356 0583 |
| admin@cresen.co | |
| Phone | 619 356 0583 |
| admin@cresen.co |
Operating and Storage Conditions
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08809900940025 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K220996
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 | 2024-03-11 |
| Device Publish Date | 2024-03-01 |
On-Brand Devices [Duoblade]
| 08809900940001 | DB1SEP |
| 08809900940070 | DB1SP-TH |
| 08809900940063 | DB1SP-T |
| 08809900940056 | DB1SP-H |
| 08809900940049 | DB1SP |
| 08809900940032 | DB1SEP-TH |
| 08809900940025 | DB1SEP-T |
| 08809900940018 | DB1SEP-H |
Trademark Results [Duoblade]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DUOBLADE 85893936 not registered Dead/Abandoned |
Choi, Jae K. 2013-04-03 |
 DUOBLADE 79353228 not registered Live/Pending |
CHOI, In sang 2022-09-07 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.