| Primary Device ID | D824PS5WC50132 |
| NIH Device Record Key | d69531bc-16d1-4e21-be56-9ada9698bada |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Solution5 Implant Pack |
| Version Model Number | PS5WC5013 |
| 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 | D824PS5WC50130 [Primary] |
| HIBCC | D824PS5WC50131 [Package] Contains: D824PS5WC50130 Package: [10 Units] In Commercial Distribution |
| HIBCC | D824PS5WC50132 [Package] Contains: D824PS5WC50130 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 | 2017-02-06 |
| D824PS5WC50152 | Ø5.0mm x L15.0 mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PS5WC50132 | Ø5.0mm x L13.0 mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PS5WC50112 | Ø5.0mm x L11.0 mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PS5WC50102 | Ø5.0mm x L10.0 mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PS5WC50082 | Ø5.0mm x L8.0 mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PS5WC50072 | Ø5.0mm x L7.0 mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PS5WC45152 | Ø4.5mm x L15.0 mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PS5WC45132 | Ø4.5mm x L13.0 mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PS5WC45112 | Ø4.5mm x L11.0 mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PS5WC45102 | Ø4.5mm x L10.0 mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PS5WC45082 | Ø4.5mm x L8.0 mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PS5WC45072 | Ø4.5mm x L7.0 mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PS5WC40152 | Ø4.0mm x L15.0 mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PS5WC40132 | Ø4.0mm x L13.0 mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PS5WC40112 | Ø4.0mm x L11.5 mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PS5WC40102 | Ø4.0mm x L10.0 mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PS5WC40082 | Ø4.0mm x L8.5 mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PS5WC40072 | Ø4.0mm x L7.0 mm, Conical Connection, Wide Platform with Cover Screw & Mount |
| D824PS5RC35152 | Ø3.5mm x L15.0mm, Conical Connection, Regular Platform with Cover Screw & Mount |
| D824PS5RC35132 | Ø3.5mm x L13.0mm, Conical Connection, Regular Platform with Cover Screw & Mount |
| D824PS5RC35112 | Ø3.5mm x L11.5.0mm, Conical Connection, Regular Platform with Cover Screw & Mount |
| D824PS5RC35102 | Ø3.5mm x L10.0mm, Conical Connection, Regular Platform with Cover Screw & Mount |
| D824PS5RC35082 | Ø3.5mm x L8.5 mm, Conical Connection, Regular Platform with Cover Screw & Mount |
| D824PS5NC32162 | Ø3.25mm x L16.0mm, Conical Connection, Narrow Platform with Cover Screw & Mount |
| D824PS5NC32132 | Ø3.25mm x L13.0mm, Conical Connection, Narrow Platform with Cover Screw & Mount |
| D824PS5NC32112 | Ø3.25mm x L11.5mm, Conical Connection, Narrow Platform with Cover Screw & Mount |
| D824PS5NC32102 | Ø3.25mm x L10.0mm, Conical Connection, Narrow Platform with Cover Screw & Mount |
| D824PS5NC30162 | Ø3.0mm x L16.0mm, Conical Connection, Narrow Platform with Cover Screw & Mount |
| D824PS5NC30132 | Ø3.0mm x L13.0mm, Conical Connection, Narrow Platform with Cover Screw & Mount |
| D824PS5NC30112 | Ø3.0mm x L11.5mm, Conical Connection, Narrow Platform with Cover Screw & Mount |
| D824PS5NC30102 | Ø3.0mm x L10.0mm, Conical Connection, Narrow Platform with Cover Screw & Mount |
| D824PS2NC32162 | Ø3.25mm x L16.0mm, Conical Connection, Narrow Platform with Cover Screw & Mount |
| D824PS2NC32132 | Ø3.25mm x L13.0mm, Conical Connection, Narrow Platform with Cover Screw & Mount |
| D824PS2NC32112 | Ø3.25mm x L11.0mm, Conical Connection, Narrow Platform with Cover Screw & Mount |
| D824PS2NC32102 | Ø3.25mm x L10.0mm, Conical Connection, Narrow Platform with Cover Screw & Mount |