XERF
GUDID 08809447657981
Lutronic Corporation
Radio-frequency skin/body contouring system| Primary Device ID | 08809447657981 |
| NIH Device Record Key | 127fe359-69bc-473a-9680-c149f9d21136 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | XERF |
| Version Model Number | XERF |
| Company DUNS | 688282516 |
| Company Name | Lutronic Corporation |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08809447657981 [Primary] |
FDA Product Code
| GEI | Electrosurgical, Cutting & Coagulation & Accessories |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-03 |
| Device Publish Date | 2025-08-26 |
Devices Manufactured by Lutronic Corporation
| 08809447655666 - CLARITY II | 2025-09-04 |
| 08809447655673 - CLARITY II | 2025-09-04 |
| 08809447655680 - CLARITY II | 2025-09-04 |
| 08809447655697 - CLARITY II | 2025-09-04 |
| 08809447655703 - CLARITY II | 2025-09-04 |
| 08809447655710 - CLARITY II | 2025-09-04 |
| 08809447655727 - CLARITY II | 2025-09-04 |
| 08809447655840 - CLARITY II | 2025-09-04 O Type IntelliTrak tip |
Trademark Results [XERF]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 XERF 98193055 not registered Live/Pending |
Lutronic Corporation 2023-09-22 |
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