| Primary Device ID | 00810021869728 |
| NIH Device Record Key | a448441d-6f24-4281-9f76-cf23fda7558a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SubChon |
| Version Model Number | C01 S1211 |
| Catalog Number | C01 S1211 |
| Company DUNS | 079700711 |
| Company Name | IN2BONES USA, LLC |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| 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 |
|---|---|
| GS1 | 00810021869728 [Primary] |
| LXH | Orthopedic manual surgical instrument |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-12-31 |
| Device Publish Date | 2024-12-10 |
| 00810021864259 | SubChon Implant Sizer, NS |
| 00810021869728 | Instrument Kit,Size 11 mm Back Load Single-Use,Sterile |
| 00810021869711 | Instrument Kit,Size 9 mm,Back Load Single-Use,Sterile |
| 00810021869704 | Instrument Kit,Size 7 mm,Back Load Single-Use,Sterile |
| 00810021869698 | Instrument Kit,Size 5 mm,Back Load Single-Use,Sterile |
| 00810021866819 | SubChon Instrument Kit, Size 11mm, Single-Use, Sterile |
| 00810021866802 | SubChon Instrument Kit, Size 9mm, Single-Use, Sterile |
| 00810021866796 | SubChon Instrument Kit, Size 7mm, Single-Use, Sterile |
| 00810021866789 | SubChon Instrument Kit, Size 5mm, Single-Use, Sterile |
| 00810021866765 | SubChon Sizing Kit, Single-Use, Sterile |
| 00810021866758 | SubChon Instrument Kit, Size 11mm, Single-Use, Sterile |
| 00810021866741 | SubChon Instrument Kit, Size 9mm, Single-Use, Sterile |
| 00810021866734 | SubChon Instrument Kit, Size 7mm, Single-Use, Sterile |
| 00810021866727 | SubChon Instrument Kit, Size 5mm, Single-Use, Sterile |
| 00810021864358 | SubChon System Reusable Instrument Tray |