| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00628110259363 | 1859 | Sterile protective cover for the MolecuLight i:X to be used in a surgical environment. | KKX | Drape, Surgical | 2 | i:X Sterile Surgical Sleeve Convenience Kit | |
| 2 | 00628110259325 | 1153-11 | The MolecuLight i:X is a handheld imaging tool that allows clinicians diagnosing The MolecuLight i:X is a handheld imaging tool that allows clinicians diagnosing and treating skin wounds, at the point of care, to:(i) View and digitally record images of a wound,(ii) Measure and digitally record the size of a wound, and(iii) View and digitally record images of fluorescence emitted from a wound when exposed to an excitation light.The fluorescence image, when used in combination with clinical signs and symptoms, has been shown to increase the likelihood that clinicians can identify wounds containing bacterial loads >10^4 CFU per grams as compared to examination of clinical signs and symptoms alone. The MolecuLight i:X device should not be used to rule-out the presence of bacteria in a wound. | QJF,FXN | Autofluorescence Imaging Adjunct Tool For Wounds,Tape, Camera, Surgical | 1 | MolecuLight i:X System | |
| 3 | 00628110259295 | 1426 | Drapes that are individually packaged for one-time use to create an optimal ligh Drapes that are individually packaged for one-time use to create an optimal lighting environment for imaging wounds while using the MolecuLight i:X. | PUI | Drape, Surgical, Exempt | 2 | MolecuLight DarkDrape | |
| 4 | 00628110259394 | 1973 | Drapes individually packaged for one-time use to create an optimal lighting envi Drapes individually packaged for one-time use to create an optimal lighting environment for imaging wounds using the MolecuLightDX. | PUI | Drape, Surgical, Exempt | 2 | MolecuLightDX DarkDrape |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00628110259387 | 2094 | The MolecuLightDX is a handheld imaging tool that allows clinicians diagnosing a The MolecuLightDX is a handheld imaging tool that allows clinicians diagnosing and treating skin wounds, at the point of care, to:(i) View and digitally record images of a wound, (ii) Measure and digitally record the size of a wound, and (iii) View and digitally record images of fluorescence emitted from a wound when exposed to an excitation light. The fluorescence image, when used in combination with clinical signs and symptoms, has been shown to increase the likelihood that clinicians can identify wounds containing bacterial loads >10^4 CFU per grams as compared to examination of clinical signs and symptoms alone. The MolecuLightDX device should not be used to rule-out the presence of bacteria in a wound. | MolecuLightDX System | MOLECULIGHT INC | |
| 2 | 00628110259325 | 1153-11 | The MolecuLight i:X is a handheld imaging tool that allows clinicians diagnosing The MolecuLight i:X is a handheld imaging tool that allows clinicians diagnosing and treating skin wounds, at the point of care, to:(i) View and digitally record images of a wound,(ii) Measure and digitally record the size of a wound, and(iii) View and digitally record images of fluorescence emitted from a wound when exposed to an excitation light.The fluorescence image, when used in combination with clinical signs and symptoms, has been shown to increase the likelihood that clinicians can identify wounds containing bacterial loads >10^4 CFU per grams as compared to examination of clinical signs and symptoms alone. The MolecuLight i:X device should not be used to rule-out the presence of bacteria in a wound. | MolecuLight i:X System | MOLECULIGHT INC |