| Primary Device ID | D813SPD14170 |
| NIH Device Record Key | 1fdfbf1e-8fac-4997-9c53-cd79dcc4933d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | The Gripper® |
| Version Model Number | SPD1417 |
| Catalog Number | SPD1417 |
| 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 | 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 | D813SPD14170 [Primary] |
| EHY | Tray, Impression, Preformed |
| 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 |
| D813SPD15410 | GRIPPER TRAY SIDELES POSTERIOR |
| D813SPD14170 | GRIPPER TRAY FULL ARCH LG |
| D813SPD14160 | GRIPPER TRAY 3/4 ARCH |
| D813SPD14150 | GRIPPER TRAY POSTERIOR |
| D813SPD14140 | GRIPPER TRAY ANTERIOR |
| D813SPD14180 | GRIPPER TRAY FULL ARCH MED |