| Primary Device ID | D8130339585030 |
| NIH Device Record Key | 4f9f0d06-b83c-45d0-9376-ee1d99b62ee0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sapphire® Plus |
| Version Model Number | 033958503 |
| Catalog Number | 033958503 |
| 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 | true |
| 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 | true |
| OTC Over-The-Counter | false |
| 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 | D8130339585030 [Primary] |
| EBZ | Activator, Ultraviolet, For Polymerization |
| 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 |
| D813033968000L0 | LT SAPPHIRE PLUS LOANER |
| D8130339680000 | LT SAPPHIRE PLUS |
| D813033958000L0 | LT SAPPHIRE LOANER |
| D8130339587010 | LT SAPH PLUS UPGRADE KIT |
| D8130339585060 | LT SAPH 2mm TACKING TIP PKG |
| D8130339585030 | LT SAPPHIRE 12mm TIP PKG |
| D8130339585010 | LT SAPPHIRE 4mm TIP PKG |
| D8130305991050 | DISPENSING GUN 25mL DCHMB SY |
| D8130305972750 | LT SAPH ROLLING STAND W/ARM |
| D8130305953750 | CRYSTAL ARM w/HLDR & PIVOT |
| D8130303952500 | SAPH WHT CRYSTAL KIT |