| Primary Device ID | D813ALED60 |
| NIH Device Record Key | 116d61db-8bf9-47a0-a1e8-f34e2b591f9c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PeriOptix® |
| Version Model Number | A-LED6 |
| Catalog Number | A-LED6 |
| 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 | D813ALED60 [Primary] |
| HOY | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) |
| 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 |
| D813LPMM0 | PUPILIOMETER |
| D813AREPKITNA0 | PERIOPTIX REP KIT US/CN |
| D813ALED60 | LUMIPRO HEADLIGHT SYSTEM |
| D813ALED5R0 | FIREFLY UNIT RED |
| D813ALED5B0 | FIREFLY UNIT BLUE |
| D813ALED50 | FIREFLY UNIT |
| D813200POPTIX0 | PERIOPTIX KIT ASSEMBLY |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PERIOPTIX 85799256 4354094 Live/Registered |
Den-Mat Holdings, LLC 2012-12-10 |