| Primary Device ID | B0671100010L0 |
| NIH Device Record Key | 73ac4f2a-ce93-42e4-bb04-825b69ab7b09 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LASE Endoscopic Discectomy Set |
| Version Model Number | 1100-010L |
| Catalog Number | 1100-010L |
| Company DUNS | 010316284 |
| Company Name | CLARUS MEDICAL, 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 763-525-8400 |
| admin@clarus-medical.com | |
| Phone | 763-525-8400 |
| admin@clarus-medical.com |
| Storage Environment Temperature | Between -18 Degrees Celsius and 52 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 52 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B0671100010L0 [Primary] |
| GEX | Powered Laser Surgical Instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-20 |
| B0671100010L0 | LASE Endoscopic Discectomy System (Long), with Tubing Set. For use with HO:YAG lasers with a Tr |
| B06711000100 | LASE Endoscopic Discectomy System, with Tubing Set. For use with HO:YAG lasers with a Trimedyne |
| B0671100002SHORT0 | LASE Endoscopic Discectomy Set (Short), with Tubing Set. For use with HO:YAG Lasers with a SMA |
| B0671100002S0 | LASE Endoscopic Discectomy Set (Short), with Tubing Set. For use with HO:YAG Lasers with a SMA |
| B06711000020 | LASE Endoscopic Discectomy Set, with Tubing Set. For use with HO:YAG Lasers with a SMA 905 conn |