| Primary Device ID | 00889795016119 |
| NIH Device Record Key | 4b01e682-e7ad-4313-9954-0877655c3aa6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Gorilla Plating System |
| Version Model Number | P01-900-0004 |
| Catalog Number | P01-900-0004 |
| Company DUNS | 042961576 |
| Company Name | PARAGON 28, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| 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 | 00889795016119 [Primary] |
| FSM | TRAY, SURGICAL, INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00889795016119]
Moist Heat or Steam Sterilization
[00889795016119]
Moist Heat or Steam Sterilization
[00889795016119]
Moist Heat or Steam Sterilization
[00889795016119]
Moist Heat or Steam Sterilization
[00889795016119]
Moist Heat or Steam Sterilization
[00889795016119]
Moist Heat or Steam Sterilization
[00889795016119]
Moist Heat or Steam Sterilization
[00889795016119]
Moist Heat or Steam Sterilization
[00889795016119]
Moist Heat or Steam Sterilization
[00889795016119]
Moist Heat or Steam Sterilization
[00889795016119]
Moist Heat or Steam Sterilization
[00889795016119]
Moist Heat or Steam Sterilization
[00889795016119]
Moist Heat or Steam Sterilization
[00889795016119]
Moist Heat or Steam Sterilization
[00889795016119]
Moist Heat or Steam Sterilization
[00889795016119]
Moist Heat or Steam Sterilization
[00889795016119]
Moist Heat or Steam Sterilization
[00889795016119]
Moist Heat or Steam Sterilization
[00889795016119]
Moist Heat or Steam Sterilization
[00889795016119]
Moist Heat or Steam Sterilization
[00889795016119]
Moist Heat or Steam Sterilization
[00889795016119]
Moist Heat or Steam Sterilization
[00889795016119]
Moist Heat or Steam Sterilization
[00889795016119]
Moist Heat or Steam Sterilization
[00889795016119]
Moist Heat or Steam Sterilization
[00889795016119]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2021-07-08 |
| Device Publish Date | 2016-09-24 |
| 00889795017482 | BOW Implant Caddy Lid Gorilla |
| 00889795018076 | Gorilla, Ankle Fracture Caddy Base |
| 00889795018045 | Gorilla Universal Plate Caddy Lid with Strut |
| 00889795018038 | Gorilla Medial Column Arch Caddy Base |
| 00889795017550 | Universal PLate System Lid |
| 00889795017543 | Universal Plate System caddy Base |
| 00889795017536 | MTP Impant Caddy Assembly, Gorilla |
| 00889795017529 | Gorilla Lisfranc Implant Caddy, Base |
| 00889795017512 | Gorilla Lapidus Implant Caddy, Base |
| 00889795017505 | Calc Slide Implant Caddy Base |
| 00889795017499 | Gorilla Calc-Factures Implant Caddy, Base |
| 00889795017475 | BOW Implant caddy Lid, Gorilla |
| 00889795017468 | BOW Implant Caddy, Gorilla |
| 00889795017451 | Lid, Half Caddy |
| 00889795017444 | R3CON Screw Caddy Base and Lid, Gorilla |
| 00889795017437 | Case Lid, Full DIN |
| 00889795017420 | Gorilla Instrument Caddy With Lid |
| 00889795017413 | Plate Screw Caddy Base and Lid, Gorilla |
| 00889795017406 | Instrument Tray, Gorilla |
| 00889795017390 | Implant Caddy Tray, Gorilla |
| 00889795017383 | Case Base Assembly, Gorilla |
| 00889795016126 | CADDY, ALLOGRAFT, SUB TALAR & CALC CUBOID, HALF |
| 00889795016119 | CADDY, ALLOGRAFT, LAPIDUS, HALF |
| 00889795016102 | CADDY, ALLOGRAFT, EVANS AND COTTON, HALF |
| 00889795016096 | Caddy, MTP Allograft, Half |
| 00889795016089 | Caddy, Lid, Allograft, Half |
| 00889795018083 | Mini-Monster, Washer, Ø2.7mm, Flat, TiA |
| 00889795001122 | Gorilla Washer |
| 00889795018052 | Gorilla, Ankle Fx, Anatomical Fibular Plate R, 17-Hole |
| 00889795018021 | Gorilla, Plate, Med Col Arch NC-1st Met, 2.0mm Thk, Right, Lg, TiA |
| 00889795018014 | Gorilla, Plate, Med Col Arch NC-1st Met, 2.0mm Thk, Right, Md, TiA |
| 00889795018007 | Gorilla, Plate, Med Col Arch NC-1st Met, 2.0mm Thk, Right, Sm, TiA |
| 00889795017994 | Gorilla, Plate, Med Col Arch, 2.0mm Thk, Right, Lg, TiA |
| 00889795017987 | Gorilla, Plate, Med Col Arch, 2.0mm Thk, Right, Md, TiA |
| 00889795017970 | Gorilla, Plate, Med Col Arch, 2.0mm Thk, Right, Sm, TiA |
| 00889795017963 | Gorilla, Plate, Med Col Arch NC-1st Met, 2.0mm Thk, Left, Lg, TiA |
| 00889795017956 | Gorilla, Plate, Med Col Arch NC-1st Met, 2.0mm Thk, Left, Md, TiA |
| 00889795017949 | Gorilla, Plate, Med Col Arch NC-1st Met, 2.0mm Thk, Left, Sm, TiA |
| 00889795017932 | Gorilla, Plate, Med Col Arch, 2.0mm Thk, Left, Lg, TiA |
| 00889795017925 | Gorilla, Plate, Med Col Arch, 2.0mm Thk, Left, Md, TiA |
| 00889795017918 | Gorilla, Plate, Med Col Arch, 2.0mm Thk, Left, Sm, TiA |
| 00889795017901 | Gorilla, Plate, Med Col Arch, TN-NC, 1.5mm Thk, Right, Lg, TiA |
| 00889795017895 | Gorilla, Plate, Med Col Arch, TN-NC, 1.5mm Thk, Right, Md, TiA |
| 00889795017888 | Gorilla, Plate, Med Col Arch, TN-NC, 1.5mm Thk, Right, Sm, TiA |
| 00889795017871 | Gorilla, Plate, Med Col Arch, 1.5mm Thk, Right, Lg, TiA |
| 00889795017864 | Gorilla, Plate, Med Col Arch, 1.5mm Thk, Right, Md, TiA |
| 00889795017857 | Gorilla, Plate, Med Col Arch, 1.5mm Thk, Right, Sm, TiA |
| 00889795017840 | Gorilla, Plate, Med Col Arch, TN-NC, 1.5mm Thk, Left, Lg, TiA |
| 00889795017833 | Gorilla, Plate, Med Col Arch, TN-NC, 1.5mm Thk, Left, Md, TiA |
| 00889795017826 | Gorilla, Plate, Med Col Arch, TN-NC, 1.5mm Thk, Left, Sm, TiA |