| Primary Device ID | D813ZLR10180 |
| NIH Device Record Key | b7f8f9fd-3bf7-4262-ab0f-306d36427250 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SL3® |
| Version Model Number | ZLR1018 |
| Catalog Number | ZLR1018 |
| Company DUNS | 809857704 |
| Company Name | DEN-MAT HOLDINGS, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 18004336628 |
| info@denmat.com | |
| Phone | 18004336628 |
| info@denmat.com | |
| Phone | 18004336628 |
| info@denmat.com | |
| Phone | 18004336628 |
| info@denmat.com | |
| Phone | 18004336628 |
| info@denmat.com | |
| Phone | 18004336628 |
| info@denmat.com | |
| Phone | 18004336628 |
| info@denmat.com | |
| Phone | 18004336628 |
| info@denmat.com | |
| Phone | 18004336628 |
| info@denmat.com | |
| Phone | 18004336628 |
| info@denmat.com | |
| Phone | 18004336628 |
| info@denmat.com | |
| Phone | 18004336628 |
| info@denmat.com | |
| Phone | 18004336628 |
| info@denmat.com | |
| Phone | 18004336628 |
| info@denmat.com | |
| Phone | 18004336628 |
| info@denmat.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D813ZLR10180 [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 | 2022-09-30 |
| Device Publish Date | 2022-09-22 |
| D813ZLR2006A1 | SL3 DISP PERIO TIPS 7MM 25PK |
| D813ZLR2005A1 | SL3 DISP REG TIPS 5MM 25PK |
| D813ZLR20040 | SL3 FOOT PEDAL |
| D813ZLR20090 | SL3 REPLACEMENT POWER SUPPLY |
| D813ZLR20080 | SL3 HANDPIECE AUTOCLAVABLE |
| D813ZLR20030 | SL3 UNIFIBER SYSTEM |
| D813ZLR10180 | FIBERS AC-FIBER 400um 12FT |