| Primary Device ID | 00889795050670 |
| NIH Device Record Key | 65526769-54a7-4573-84ff-c5ac749d5685 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Multi System |
| Version Model Number | P99-150-0002 |
| Catalog Number | P99-150-0002 |
| 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 | 00889795050670 [Primary] |
| HXG | TAMP |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00889795050670]
Moist Heat or Steam Sterilization
[00889795050670]
Moist Heat or Steam Sterilization
[00889795050670]
Moist Heat or Steam Sterilization
[00889795050670]
Moist Heat or Steam Sterilization
[00889795050670]
Moist Heat or Steam Sterilization
[00889795050670]
Moist Heat or Steam Sterilization
[00889795050670]
Moist Heat or Steam Sterilization
[00889795050670]
Moist Heat or Steam Sterilization
[00889795050670]
Moist Heat or Steam Sterilization
[00889795050670]
Moist Heat or Steam Sterilization
[00889795050670]
Moist Heat or Steam Sterilization
[00889795050670]
Moist Heat or Steam Sterilization
[00889795050670]
Moist Heat or Steam Sterilization
[00889795050670]
Moist Heat or Steam Sterilization
[00889795050670]
Moist Heat or Steam Sterilization
[00889795050670]
Moist Heat or Steam Sterilization
[00889795050670]
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 |
| 00889795056931 | Trial Handle, Cotton, 8mm |
| 00889795056924 | Trial Handle, Cotton, 7mm |
| 00889795056917 | Trial Handle, Cotton, 5mm |
| 00889795056900 | Trial Handle, Evans, 12mm |
| 00889795056894 | Trial Handle, Evans, 8mm |
| 00889795056887 | Trial Handle, Evans, 6mm |
| 00889795054364 | Bone Fenestration Chisel, Curved |
| 00889795054357 | Osteotome, Curved, Handled, 12mm |
| 00889795054340 | Osteotome, Curved, Handled, 6mm |
| 00889795054333 | Osteotome, Curved, Handled, 3mm |
| 00889795054326 | Osteotome, Straight, Handled, 12mm |
| 00889795054319 | Osteotome, Straight, Handled, 6mm |
| 00889795054302 | Curette, 20° Angled, 7mm |
| 00889795054296 | Curette, Curved, 7mm |
| 00889795054289 | Curette, Ring, Straight, 7mm |
| 00889795054272 | Curette, Ring, 20° Angled, 7mm |
| 00889795052070 | Driver, Cannulated, Hexalobe HX6 Modified |
| 00889795050694 | P28, K-wire, Single Ended Trocar Tip, SMOOTH, 1.6 x 200 mm, SS |
| 00889795050687 | Radius Bone Tamp (change to Curved Bone Tamp) |
| 00889795050670 | Flat Bone Tamp |
| 00889795048967 | P28, Screw Forceps, Ti |
| 00889795041623 | P28 Foot Plate, Plantigrade Guide |
| 00889795041425 | K-wire, Single Ended Trocar Tip, SMOOTH, 2.3 x 150mm |
| 00889795041418 | K-wire, Single Ended Trocar Tip, SMOOTH, 2.0 x 150mm |
| 00889795041340 | Screw Driver Attachment, Solid, AO, HX-6 |
| 00889795041203 | Screw Holding Sleeve |
| 00889795041098 | Osteotome, Curved, 19mm |
| 00889795041081 | Osteotome, Curved, 13mm |
| 00889795041074 | Osteotome, Curved, 6mm |
| 00889795040954 | Osteotome, Straight, 19mm |
| 00889795040947 | Osteotome, Straight, 13mm |
| 00889795040930 | Osteotome, Straight, 6mm |
| 00889795040923 | Weil Osteotomy Clamp |
| 00889795040916 | Large Ankle Tenaculum |
| 00889795040893 | Bone Fenestration Chisel |
| 00889795040886 | The Honey Badger (Cartilage Removal Tool) |
| 00889795040855 | Lapidus Ronjeur |
| 00889795040817 | Medium Hintermann Distractor |
| 00889795040770 | Hintermann Hindfoot Distractor, 2.5 & 3.0 K-wire |
| 00889795040398 | Mini-AO, Non-Ratcheting Handle Streamline, Cannulated |
| 00889795040381 | Mini-AO, Ratcheting Handle Streamline, Cannulated |
| 00889795040374 | Mini-AO, Ratchet Handle, Purple |
| 00889795040367 | T-Handle, 3/16" Sq. Adaptor, Cannulated, Ratcheting |
| 00889795034069 | K-Wire, Double Ended Trocar Tip, Smooth, 0.9 x 150mm |
| 00889795034045 | K-Wire, Single Ended Trocar Tip, Smooth, 1.4 x 100mm |
| 00889795034021 | K-Wire, Double Ended Trocar Tip, Smooth, 1.1mm x 150mm |
| 00889795019936 | P28, K-Wire, 1.6 x 150 mm, Single Trocar, SMOOTH, SS |
| 00889795019899 | P28, K-Wire Ruler |
| 00889795019882 | P28, Screw Forceps, Ti |
| 00889795153166 | K-Wire, Single Ended Trocar Tip, Smooth, 1.4 x 100mm |