| Primary Device ID | 00889795054630 |
| NIH Device Record Key | 2d3fed1e-43ca-4a15-a133-cad148b1ad09 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Monster Screw System |
| Version Model Number | P20-900-0015-1 |
| Catalog Number | P20-900-0015-1 |
| 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 | 00889795054630 [Primary] |
| FSM | TRAY, SURGICAL, INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00889795054630]
Moist Heat or Steam Sterilization
[00889795054630]
Moist Heat or Steam Sterilization
[00889795054630]
Moist Heat or Steam Sterilization
[00889795054630]
Moist Heat or Steam Sterilization
[00889795054630]
Moist Heat or Steam Sterilization
[00889795054630]
Moist Heat or Steam Sterilization
[00889795054630]
Moist Heat or Steam Sterilization
[00889795054630]
Moist Heat or Steam Sterilization
[00889795054630]
Moist Heat or Steam Sterilization
[00889795054630]
Moist Heat or Steam Sterilization
[00889795054630]
Moist Heat or Steam Sterilization
[00889795054630]
Moist Heat or Steam Sterilization
[00889795054630]
Moist Heat or Steam Sterilization
[00889795054630]
Moist Heat or Steam Sterilization
[00889795054630]
Moist Heat or Steam Sterilization
[00889795054630]
Moist Heat or Steam Sterilization
[00889795054630]
Moist Heat or Steam Sterilization
[00889795054630]
Moist Heat or Steam Sterilization
[00889795054630]
Moist Heat or Steam Sterilization
[00889795054630]
Moist Heat or Steam Sterilization
[00889795054630]
Moist Heat or Steam Sterilization
[00889795054630]
Moist Heat or Steam Sterilization
[00889795054630]
Moist Heat or Steam Sterilization
[00889795054630]
Moist Heat or Steam Sterilization
[00889795054630]
Moist Heat or Steam Sterilization
[00889795054630]
Moist Heat or Steam Sterilization
[00889795054630]
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 |
| 00889795056719 | 1.2 X 150 Mm K Wire, Single Ended Trocar Tip, Threaded |
| 00889795055057 | JOUST Precision Beaming Compression Cap, Sm |
| 00889795055040 | JOUST Precision Beaming Compression Cap, Lg |
| 00889795055033 | JOUST Precision Beaming Reduction Guide Tube |
| 00889795055026 | JOUST Precision Beaming Reduction Jig |
| 00889795055019 | Monster Beam, Instrument Tray |
| 00889795055002 | Monster Beam, Instrument Case Base |
| 00889795054999 | Monster Beam, Case Lid |
| 00889795054982 | JOUST Precision Beaming Guidewire Sleeve 1.4mm |
| 00889795054975 | 4.6mm Drill Guide Tube |
| 00889795054968 | Reduction Guide, Tommy Bar |
| 00889795054951 | JOUST Reduction Device Caddy Lid |
| 00889795054944 | JOUST Reduction Device Caddy Insert |
| 00889795054937 | JOUST Reduction Device Caddy Base |
| 00889795054920 | JOUST Precision Beaming Guidewire Sleeve 2.3mm |
| 00889795054913 | JOUST Precision Beaming Guidewire Sleeve 1.6mm |
| 00889795054906 | Monster Beam, Ø7.2 Solid Part. Thrd Implant Tray |
| 00889795054890 | Monster Beam, Ø7.2 Solid Full Thrd Implant Tray |
| 00889795054883 | Monster Beam, Ø7.2 Cannulated Part. Thrd Implant Tray |
| 00889795054876 | Monster Beam, Ø7.2 Cannulated Full Thrd Implant Tray |
| 00889795054869 | Monster Beam, Implant Case Base |
| 00889795054852 | Monster Beam, Ø5.5 Solid Implant Tray |
| 00889795054845 | Monster Beam, Ø5.5 Cannulated Implant Tray |
| 00889795054838 | Monster Beam, Ø5.0 Solid Implant Tray |
| 00889795054821 | Monster Beam, Ø5.0 Cannulated Implant Tray |
| 00889795054814 | Beaming,Ø7.2 Instrument Caddy, Lid |
| 00889795054807 | Beaming, Ø7.2 Screw Caddy, Lid |
| 00889795054791 | Beaming, Ø7.2 Instrument Caddy, Base |
| 00889795054784 | Beaming, Ø7.2 Screw Caddy, Base |
| 00889795054753 | Caddy, Mini Monster, Instrument Lid |
| 00889795054746 | Beaming Instrument Case, K-Wire Tray |
| 00889795054739 | MINI-MONSTER Solid Caddy, Lid |
| 00889795054715 | Caddy, Mini Monster, 3.0mm Lag Screw, Instrument Base |
| 00889795054708 | Caddy, Mini Monster, 3.0mm Lag Screw, Lid |
| 00889795054692 | Caddy, Mini Monster, 3.0mm Lag Screw, Base |
| 00889795054685 | Caddy, Mini Monster, 2.5mm Lag Screw, Instrument Base |
| 00889795054678 | Caddy, Mini Monster, 2.5mm Lag Screw, Lid |
| 00889795054661 | Caddy, Mini Monster, 2.5mm Lag Screw, Base |
| 00889795054654 | Caddy, Mini Monster, 2.0mm Lag Screw, Instrument Base |
| 00889795054647 | Caddy, Mini Monster, 2.0mm Lag Screw, Lid |
| 00889795054630 | Mini Monster, 2.0mm Lag Screw Caddy Base |
| 00889795054623 | Caddy, Mini Monster, 4.0mm Lag Screw, Instrument Base |
| 00889795054616 | Caddy, Mini Monster, 4.0mm Lag Screw, Lid |
| 00889795054609 | Caddy, Mini Monster, 4.0mm Lag Screw, Base |
| 00889795054593 | Caddy, Mini Monster, 3.5mm Lag Screw, Instrument Base |
| 00889795054586 | Caddy, Mini Monster, 3.5mm Lag Screw, Lid |
| 00889795054579 | Caddy, Mini Monster, 3.5mm Lag Screw, Base |
| 00889795054562 | Long K-wire Caddy Assembly |
| 00889795054555 | Short K-wire Caddy Assembly |
| 00889795052384 | Driver, Cannulated, Hexalobe HX15 |