| Primary Device ID | D824PIRH50102 |
| NIH Device Record Key | cc0b6682-dd18-458c-a0e9-3e8a4e218857 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Immediate Implant Pack |
| Version Model Number | PIRH5010 |
| Company DUNS | 080321629 |
| Company Name | SURGIKOR, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| 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 | D824PIRH50100 [Primary] |
| HIBCC | D824PIRH50101 [Package] Contains: D824PIRH50100 Package: [10 Units] In Commercial Distribution |
| HIBCC | D824PIRH50102 [Package] Contains: D824PIRH50100 Package: [4 Units] In Commercial Distribution |
| DZE | Implant, Endosseous, Root-Form |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-02-07 |
| D824PIWC80082 | Ø8.0mm x L8.0mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PIWC80062 | Ø8.0mm x L6.0mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PIWC70102 | Ø7.0mm x L10.0mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PIWC70082 | Ø7.0mm x L8.0mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PIWC70062 | Ø7.0mm x L6.0mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PIWC60162 | Ø6.0mm x L16.0mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PIWC60132 | Ø6.0mm x L13.0mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PIWC60112 | Ø6.0mm x L11.0mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PIWC60102 | Ø6.0mm x L10.0mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PIWC60082 | Ø6.0mm x L8.0mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PIWC60062 | Ø6.0mm x L6.0mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PIWC50162 | Ø5.0mm x L16.0mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PIWC50132 | Ø5.0mm x L13.0mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PIWC50112 | Ø5.0mm x L11.0mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PIWC50102 | Ø5.0mm x L10.0mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PIWC50082 | Ø5.0mm x L8.0mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PIWC50062 | Ø5.0mm x L6.0mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PIWC45162 | Ø4.5mm x L16.0mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PIWC45132 | Ø4.5mm x L13.0mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PIWC45112 | Ø4.5mm x L11.0mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PIWC45102 | Ø4.5mm x L10.0mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PIWC45082 | Ø4.5mm x L8.0mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PIWC45062 | Ø4.5mm x L6.0mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PIWC42162 | Ø4.2mm x L16.0mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PIWC42132 | Ø4.2mm x L13.0mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PIWC42112 | Ø4.2mm x L11.0mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PIWC42102 | Ø4.2mm x L10.0mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PIWC42082 | Ø4.2mm x L8.0mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PIRH80102 | Ø8.0mm x L10.0mm, Hex Connection, Regular Platform with Cover Screw & Mount |
| D824PIRH80082 | Ø8.0mm x L8.0mm, Hex Connection, Regular Platform with Cover Screw & Mount |
| D824PIRH80062 | Ø8.0mm x L6.0mm, Hex Connection, Regular Platform with Cover Screw & Mount |
| D824PIRH70102 | Ø7.0mm x L10.0mm, Hex Connection, Regular Platform with Cover Screw & Mount |
| D824PIRH70082 | Ø7.0mm x L8.0mm, Hex Connection, Regular Platform with Cover Screw & Mount |
| D824PIRH70062 | Ø7.0mm x L6.0mm, Hex Connection, Regular Platform with Cover Screw & Mount |
| D824PIRH60162 | Ø6.0mm x L16.0mm, Hex Connection, Regular Platform with Cover Screw & Mount |
| D824PIRH60131 | Ø6.0mm x L13.0mm, Hex Connection, Regular Platform with Cover Screw & Mount |
| D824PIRH60112 | Ø6.0mm x L11.0mm, Hex Connection, Regular Platform with Cover Screw & Mount |
| D824PIRH60102 | Ø6.0mm x L10.0mm, Hex Connection, Regular Platform with Cover Screw & Mount |
| D824PIRH60082 | Ø6.0mm x L8.0mm, Hex Connection, Regular Platform with Cover Screw & Mount |
| D824PIRH60062 | Ø6.0mm x L6.0mm, Hex Connection, Regular Platform with Cover Screw & Mount |
| D824PIRH50162 | Ø5.0mm x L16.0mm, Hex Connection, Regular Platform with Cover Screw & Mount |
| D824PIRH50132 | Ø5.0mm x L13.0mm, Hex Connection, Regular Platform with Cover Screw & Mount |
| D824PIRH50112 | Ø5.0mm x L11.0mm, Hex Connection, Regular Platform with Cover Screw & Mount |
| D824PIRH50102 | Ø5.0mm x L10.0mm, Hex Connection, Regular Platform with Cover Screw & Mount |
| D824PIRH50082 | Ø5.0mm x L8.0mm, Hex Connection, Regular Platform with Cover Screw & Mount |
| D824PIRH50062 | Ø5.0mm x L6.0mm, Hex Connection, Regular Platform with Cover Screw & Mount |
| D824PIRH45162 | Ø4.5mm x L16.0mm, Hex Connection, Regular Platform with Cover Screw & Mount |
| D824PIRH45132 | Ø4.5mm x L13.0mm, Hex Connection, Regular Platform with Cover Screw & Mount |
| D824PIRH45112 | Ø4.5mm x L11.0mm, Hex Connection, Regular Platform with Cover Screw & Mount |
| D824PIRH45102 | Ø4.5mm x L10.0mm, Hex Connection, Regular Platform with Cover Screw & Mount |