| Primary Device ID | D8451151116 |
| NIH Device Record Key | be3ed85c-dcfe-4218-bb49-d9f42076b7a5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | POUR-PLUS |
| Version Model Number | 1151116 |
| Catalog Number | 1151116 |
| Company DUNS | 202016064 |
| Company Name | Denplus Inc |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D8451151116 [Primary] |
| EBI | Resin, Denture, Relining, Repairing, Rebasing |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-04-30 |
| D8451152200 | POUR-PLUS LIQUID, 500 ml |
| D8451152100 | POUR-PLUS LIQUID, 250 ml |
| D8451151316 | POUR-PLUS, ORI, 11.3 kg |
| D8451151307 | POUR-PLUS, MDP, 11.3 kg |
| D8451151305SF0 | POUR-PLUS, LPI, WITHOUT FIBERS, 11.3 kg |
| D8451151305 | POUR-PLUS, LPI, 11.3 kg |
| D8451151302 | POUR-PLUS, LPL, 11.3 kg |
| D8451151300 | POUR-PLUS, CLR, 11.3 kg |
| D8451151216 | POUR-PLUS, ORI, 2.3 kg |
| D8451151207 | POUR-PLUS, MDP, 2.3 kg |
| D8451151205 | POUR-PLUS, LPI, 2.3 kg |
| D8451151202 | POUR-PLUS, LPL, 2.3 kg |
| D8451151200 | POUR-PLUS, CLR, 2.3 kg |
| D8451151116 | POUR-PLUS, ORI, 454 g |
| D8451151107 | POUR-PLUS, MDP, 454 g |
| D8451151105 | POUR-PLUS, LPI, 454 g |
| D8451151102 | POUR-PLUS, LPL, 454 g |
| D8451151100 | POUR-PLUS, CLR, 454 g |