| Primary Device ID | D813LR1001L0 |
| NIH Device Record Key | ada9165b-8914-482a-b854-b50d3e3a504b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SOL® |
| Version Model Number | LR1001L |
| Catalog Number | LR1001L |
| Company DUNS | 809857704 |
| Company Name | DEN-MAT HOLDINGS, LLC |
| 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 | true |
| Serial Number | false |
| 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 |
| Phone | 1-800-433-6628 |
| info@denmat.com | |
| Phone | 1-800-433-6628 |
| info@denmat.com |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D813LR1001L0 [Primary] |
| GEX | Powered Laser Surgical Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-11-08 |
| Device Publish Date | 2016-09-24 |
| D813LR10450 | KT SOL WIRELESS UPGRADE |
| D813LR10101 | SOL/SAPH ASSY 300um TIP 25pc |
| D813LR10040 | SOL FOOT PEDAL ASSY |
| D813LR1001WL0 | SOL WIRELESS LOANER |
| D813LR1001W0 | SOL LASER SYSTEM INTG WIRELESS |
| D813LR1001L0 | SOL LASER SYSTEM INTG LOANER |
| D813LR1001DW0 | SOL LASER INTG WIRELESS-DEALER |
| D813LR100060 | SOL HANDPIECE REPLACEMENT KIT |
| D81303398002801 | SOL/SAPH LSR 400um TIPS 25pc |
| D813LR1008CCD0 | CC LASER SAFETY GLASSES |
| D813LR10080 | LASER EYEWEAR |
| D813LR1001WINT0 | SOL INTEGRATED WIRLESS IT |