| Primary Device ID | 00810022403112 |
| NIH Device Record Key | 48599698-7e4d-4a14-8320-27bf0ea8312f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CORE Shoulder System |
| Version Model Number | 87-9138 |
| Company DUNS | 827608774 |
| Company Name | Link Bio Corp |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| 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 |
|---|---|
| GS1 | 00810022403112 [Primary] |
| FOX | Stand, Infusion |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-06-12 |
| Device Publish Date | 2025-06-04 |
| 00810022403204 | Drill Guide Probe |
| 00810022403198 | 28mm Probe - Right |
| 00810022403181 | 24mm Probe - Right |
| 00810022403174 | 20mm Probe - Right |
| 00810022403167 | 16mm Probe - Right |
| 00810022403150 | 28mm Probe - Left |
| 00810022403143 | 24mm Probe - Left |
| 00810022403136 | 20mm Probe - Left |
| 00810022403129 | 16mm Probe - Left |
| 00810022403112 | Stand/Cart for Workstation |
| 00810022403105 | Workstation AC Power Adapter |
| 00810022403099 | Workstation |
| 00810022403082 | Instrument Tray |
| 00810022403068 | COREmote - Power Unit |
| 00810022403051 | COREmote - Sensor Unit |