| Primary Device ID | D824SW153WC0 |
| NIH Device Record Key | 45965399-2d3c-46a5-b9f8-18409b9cca79 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 15 Shouldered Abutment - Wide Emergence |
| Version Model Number | SW153WC |
| 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 | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D824SW153WC0 [Primary] |
| DZE | Implant, Endosseous, Root-Form |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D824SW153WC0]
Moist Heat or Steam Sterilization
[D824SW153WC0]
Moist Heat or Steam Sterilization
[D824SW153WC0]
Moist Heat or Steam Sterilization
[D824SW153WC0]
Moist Heat or Steam Sterilization
[D824SW153WC0]
Moist Heat or Steam Sterilization
[D824SW153WC0]
Moist Heat or Steam Sterilization
[D824SW153WC0]
Moist Heat or Steam Sterilization
[D824SW153WC0]
Moist Heat or Steam Sterilization
[D824SW153WC0]
Moist Heat or Steam Sterilization
[D824SW153WC0]
Moist Heat or Steam Sterilization
[D824SW153WC0]
Moist Heat or Steam Sterilization
[D824SW153WC0]
Moist Heat or Steam Sterilization
[D824SW153WC0]
Moist Heat or Steam Sterilization
[D824SW153WC0]
Moist Heat or Steam Sterilization
[D824SW153WC0]
Moist Heat or Steam Sterilization
[D824SW153WC0]
Moist Heat or Steam Sterilization
[D824SW153WC0]
Moist Heat or Steam Sterilization
[D824SW153WC0]
Moist Heat or Steam Sterilization
[D824SW153WC0]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-08-16 |
| Device Publish Date | 2019-08-08 |
| D824SW153WC0 | "4.3mm x L7.5mm, w/ 3mm Shoulder Height, 15Deg. Angle,Wide Emergence, Conical Connection, Wide P |
| D824SW152WC0 | 4.3mm x L7.5mm, w/ 2mm Shoulder Height,15Deg. Angle,Wide Emergence, ConicalConnection, Wide Plat |