Primary Device ID | 00889795019899 |
NIH Device Record Key | 8cbe1715-ae80-453d-8ee1-ca2328990810 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Multi System |
Version Model Number | P99-150-0005 |
Catalog Number | P99-150-0005 |
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 | 00889795019899 [Primary] |
LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00889795019899]
Moist Heat or Steam Sterilization
[00889795019899]
Moist Heat or Steam Sterilization
[00889795019899]
Moist Heat or Steam Sterilization
[00889795019899]
Moist Heat or Steam Sterilization
[00889795019899]
Moist Heat or Steam Sterilization
[00889795019899]
Moist Heat or Steam Sterilization
[00889795019899]
Moist Heat or Steam Sterilization
[00889795019899]
Moist Heat or Steam Sterilization
[00889795019899]
Moist Heat or Steam Sterilization
[00889795019899]
Moist Heat or Steam Sterilization
[00889795019899]
Moist Heat or Steam Sterilization
[00889795019899]
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 |