| Primary Device ID | D813ZLR2006A1 |
| NIH Device Record Key | 004ac58b-e416-4c75-843b-8461430d1218 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SL3® |
| Version Model Number | ZLR2006A |
| Catalog Number | ZLR2006A |
| Company DUNS | 809857704 |
| Company Name | DEN-MAT HOLDINGS, LLC |
| Device Count | 25 |
| 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 | true |
| 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 |
| Length | 7 Millimeter |
| Length | 7 Millimeter |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D813ZLR2006A0 [Unit of Use] |
| HIBCC | D813ZLR2006A1 [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 |
| 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 |