| Primary Device ID | D813BLSR30060 |
| NIH Device Record Key | d0f60e44-40d4-482c-91d4-4ccb1894543b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | STERLING® |
| Version Model Number | BLSR3006 |
| Catalog Number | BLSR3003 |
| 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 | 1-800-4336628 |
| info@denmat.com | |
| Phone | 1-800-4336628 |
| info@denmat.com |
| Handling Environment Temperature | Between 6 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 6 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 6 Degrees Celsius and 30 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 6 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D813BLSR30060 [Primary] |
| GEX | Powered Laser Surgical Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-02-28 |
| Device Publish Date | 2019-01-28 |
| D813BLSR30080 | LSR WIRELESS FOOTPEDAL BENCO |
| D813BLSR30060 | LSR CHARGING BASE BENCO |
| D813BLSR30030 | LASER UNIT BENCO |
| D813BLSR1013A1 | LSR PERIO TIP 7mm 25pk BENCO |
| D813BLSR1012A1 | LSR REG TIP 5mm 25pk BENCO |
| D813BLSR3003L0 | BENCO LASER LOANER UNIT |