| Primary Device ID | 00889795151803 |
| NIH Device Record Key | a7813a3f-355d-4778-9896-fbf55b14c7e6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Special Instrument |
| Version Model Number | SP99-900-RCCB |
| Catalog Number | SP99-900-RCCB |
| Company DUNS | 042961576 |
| Company Name | Paragon 28, Inc. |
| 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 | false |
| 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 | 00889795151803 [Primary] |
| FSM | TRAY, SURGICAL, INSTRUMENT |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-11-24 |
| Device Publish Date | 2025-11-14 |
| 00889795146564 | Specialty Instrument, Metatarsal Pusher |
| 00889795151780 | Special Instrument, Straight Nail Short Dual Calc Screw Guide Assembly |
| 00889795151773 | Special Instrument, Straight Nail Short Calc Screw K-wire Guide |
| 00889795151766 | Special Instrument, Straight Nail Short Calc Screw Drill Guide |
| 00889795153623 | Special Instrument, Calc Slide Obturator, 12mm |
| 00889795153616 | Special Instrument, Calc Slide Obturator, 10mm |
| 00889795154064 | Reduction Clamp Olive Wire, 35mm Thread |
| 00889795154057 | Reduction Clamp Olive Wire, 30mm Thread |
| 00889795154040 | Reduction Clamp Olive Wire, 25mm Thread |
| 00889795154033 | Reduction Clamp Olive Wire, 20mm Thread |
| 00889795151810 | Reduction Clamp, Caddy Lid |
| 00889795151803 | Reduction Clamp, Caddy Base |
| 00889795151797 | Reduction Clamp |