| Primary Device ID | 00889795052483 |
| NIH Device Record Key | ba179e8d-2be1-4ad4-862b-eaa11aa65382 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Small Bone Phantom Intramedullary Nail System |
| Version Model Number | P30-000-KWT3 |
| Catalog Number | P30-000-KWT3 |
| Company DUNS | 042961576 |
| Company Name | PARAGON 28, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| 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 | 00889795052483 [Primary] |
| FSM | TRAY, SURGICAL, INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00889795052483]
Moist Heat or Steam Sterilization
[00889795052483]
Moist Heat or Steam Sterilization
[00889795052483]
Moist Heat or Steam Sterilization
[00889795052483]
Moist Heat or Steam Sterilization
[00889795052483]
Moist Heat or Steam Sterilization
[00889795052483]
Moist Heat or Steam Sterilization
[00889795052483]
Moist Heat or Steam Sterilization
[00889795052483]
Moist Heat or Steam Sterilization
[00889795052483]
Moist Heat or Steam Sterilization
[00889795052483]
Moist Heat or Steam Sterilization
[00889795052483]
Moist Heat or Steam Sterilization
[00889795052483]
Moist Heat or Steam Sterilization
[00889795052483]
Moist Heat or Steam Sterilization
[00889795052483]
Moist Heat or Steam Sterilization
[00889795052483]
Moist Heat or Steam Sterilization
[00889795052483]
Moist Heat or Steam Sterilization
[00889795052483]
Moist Heat or Steam Sterilization
[00889795052483]
Moist Heat or Steam Sterilization
[00889795052483]
Moist Heat or Steam Sterilization
[00889795052483]
Moist Heat or Steam Sterilization
[00889795052483]
Moist Heat or Steam Sterilization
[00889795052483]
Moist Heat or Steam Sterilization
[00889795052483]
Moist Heat or Steam Sterilization
[00889795052483]
Moist Heat or Steam Sterilization
[00889795052483]
Moist Heat or Steam Sterilization
[00889795052483]
Moist Heat or Steam Sterilization
[00889795052483]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-10-25 |
| Device Publish Date | 2019-10-17 |
| 00889795055170 | Lapidus Cut Guide Caddy Lid |
| 00889795055163 | MET-CUNEIFORM GUIDE, RIGHT 6° |
| 00889795055156 | MET-CUNEIFORM GUIDE, RIGHT 2° |
| 00889795055149 | MET-CUNEIFORM GUIDE, LEFT 6° |
| 00889795055132 | MET-CUNEIFORM GUIDE, LEFT 4° |
| 00889795055125 | MET-CUNEIFORM GUIDE, LEFT 2° |
| 00889795055118 | Lapidus Cut Guide Caddy II |
| 00889795055101 | MET-CUNEIFORM GUIDE, RIGHT 4° |
| 00889795055095 | MIS Lapidus, Burr Guide |
| 00889795055088 | MIS Lapidus, Burr Guide, Paddle |
| 00889795055071 | MIS Lapidus, Flute Cleaner |
| 00889795055064 | MIS Lapidus Burr Guide Caddy |
| 00889795052933 | Lapidus Nail, 3-Hole, Right, 60mm |
| 00889795052926 | Lapidus Nail, 3-Hole, Right, 58mm |
| 00889795052919 | Lapidus Nail, 3-Hole, Right, 56mm |
| 00889795052902 | Lapidus Nail, 3-Hole, Right, 54mm |
| 00889795052896 | Lapidus Nail, 3-Hole, Right, 52mm |
| 00889795052889 | Lapidus Nail, 3-Hole, Right, 50mm |
| 00889795052872 | Lapidus Nail, 3-Hole, Right, 48mm |
| 00889795052865 | Lapidus Nail, 3-Hole, Right, 46mm |
| 00889795052858 | Lapidus Nail, 3-Hole, Right, 44mm |
| 00889795052841 | Lapidus Nail, 3-Hole, Right, 42mm |
| 00889795052834 | Lapidus Nail, 3-Hole, Right, 40mm |
| 00889795052827 | Lapidus Nail, 3-Hole, Right, 38mm |
| 00889795052810 | Lapidus Nail, 3-Hole, Left, 60mm |
| 00889795052803 | Lapidus Nail, 3-Hole, Left, 58mm |
| 00889795052797 | Lapidus Nail, 3-Hole, Left, 56mm |
| 00889795052780 | Lapidus Nail, 3-Hole, Left, 54mm |
| 00889795052773 | Lapidus Nail, 3-Hole, Left, 52mm |
| 00889795052766 | Lapidus Nail, 3-Hole, Left, 50mm |
| 00889795052759 | Lapidus Nail, 3-Hole, Left, 48mm |
| 00889795052742 | Lapidus Nail, 3-Hole, Left, 46mm |
| 00889795052735 | Lapidus Nail, 3-Hole, Left, 44mm |
| 00889795052728 | Lapidus Nail, 3-Hole, Left, 42mm |
| 00889795052711 | Lapidus Nail, 3-Hole, Left, 40mm |
| 00889795052544 | Lapidus Nail, 2.75mm Wire Depth Gauge |
| 00889795052537 | Lapidus Nail, Tissue Protector |
| 00889795052520 | Lapidus Nail, Torque Indicating Driver, T10 |
| 00889795052513 | PHANTOM Nail, Tube Cap, Sphere Wire |
| 00889795052506 | PHANTOM Nail, Tube Cap, Standard |
| 00889795052490 | PHANTOM Nail, Sphere Wire Tube |
| 00889795052483 | PHANTOM Nail, 2.3mm K-Wire Tube |
| 00889795052476 | PHANTOM Nail, 2.0mm K-Wire Tube |
| 00889795052469 | PHANTOM Nail, 1.6mm K-Wire Tube |
| 00889795052452 | PHANTOM Screw Caddy Base |
| 00889795052445 | PHANTOM Screw Caddy Lid |
| 00889795052438 | PHANTOM Nail Caddy Base |
| 00889795052421 | PHANTOM Nail Caddy Lid |
| 00889795052414 | PHANTOM Instrument Tray |
| 00889795052407 | PHANTOM Case Lid |