| Primary Device ID | D824UCLAPLASTIC0 |
| NIH Device Record Key | cff3e830-0d3b-4125-ac1c-dba535744aad |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PLASTIC SLEEVE FOR UCLA |
| Version Model Number | UCLAPLASTIC |
| 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 | D824UCLAPLASTIC0 [Primary] |
| DZE | Implant, Endosseous, Root-Form |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-08-21 |
| Device Publish Date | 2019-08-13 |
| D824FRC43100 - Fixation One | 2025-12-23 Ø4.3mm x L10.0mm, Conical Connection, Regular Platform |
| D824FRC43110 - Fixation One | 2025-12-23 Ø4.3mm x L11.5mm, Conical Connection, Regular Platform |
| D824FRC43130 - Fixation One | 2025-12-23 Ø4.3mm x L13.0mm, Conical Connection, Regular Platform |
| D824FRC43150 - Fixation One | 2025-12-23 Ø4.3mm x L15.0mm, Conical Connection, Regular Platform |
| D824FRC43180 - Fixation One | 2025-12-23 Ø4.3mm x L18.0mm, Conical Connection, Regular Platform |
| D824FRC50080 - Fixation One | 2025-12-23 Ø5.0mm x L8.5mm, Conical Connection, Regular Platform |
| D824FRC50100 - Fixation One | 2025-12-23 Ø5.0mm x L10.0mm, Conical Connection, Regular Platform |
| D824FRC50110 - Fixation One | 2025-12-23 Ø5.0mm x L11.5mm, Conical Connection, Regular Platform |