| Primary Device ID | 08057017760528 |
| NIH Device Record Key | 3b48e06b-2891-47d1-9b4c-a65b79c53daa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DEKA SMARTPERIO |
| Version Model Number | M128A1 |
| Catalog Number | M128A1 |
| Company DUNS | 436887608 |
| Company Name | EL.EN. SPA |
| 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 |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08057017760528 [Primary] |
| GEX | Powered Laser Surgical Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08057017760528]
Moist Heat or Steam Sterilization
[08057017760528]
Moist Heat or Steam Sterilization
[08057017760528]
Moist Heat or Steam Sterilization
[08057017760528]
Moist Heat or Steam Sterilization
[08057017760528]
Moist Heat or Steam Sterilization
[08057017760528]
Moist Heat or Steam Sterilization
[08057017760528]
Moist Heat or Steam Sterilization
[08057017760528]
Moist Heat or Steam Sterilization
[08057017760528]
Moist Heat or Steam Sterilization
[08057017760528]
Moist Heat or Steam Sterilization
[08057017760528]
Moist Heat or Steam Sterilization
[08057017760528]
Moist Heat or Steam Sterilization
[08057017760528]
Moist Heat or Steam Sterilization
[08057017760528]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-04-13 |
| Device Publish Date | 2022-04-05 |
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