| Primary Device ID | 00889795056276 |
| NIH Device Record Key | b00a32ea-2e73-4c10-aaeb-1d091f1cd845 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Baby Gorilla/Gorilla Plating System |
| Version Model Number | P50-900-3108-1 |
| Catalog Number | P50-900-3108-1 |
| 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 | 00889795056276 [Primary] |
| FSM | TRAY, SURGICAL, INSTRUMENT |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00889795056276]
Moist Heat or Steam Sterilization
[00889795056276]
Moist Heat or Steam Sterilization
[00889795056276]
Moist Heat or Steam Sterilization
[00889795056276]
Moist Heat or Steam Sterilization
[00889795056276]
Moist Heat or Steam Sterilization
[00889795056276]
Moist Heat or Steam Sterilization
[00889795056276]
Moist Heat or Steam Sterilization
[00889795056276]
Moist Heat or Steam Sterilization
[00889795056276]
Moist Heat or Steam Sterilization
[00889795056276]
Moist Heat or Steam Sterilization
[00889795056276]
Moist Heat or Steam Sterilization
[00889795056276]
Moist Heat or Steam Sterilization
[00889795056276]
Moist Heat or Steam Sterilization
[00889795056276]
Moist Heat or Steam Sterilization
[00889795056276]
Moist Heat or Steam Sterilization
[00889795056276]
Moist Heat or Steam Sterilization
[00889795056276]
Moist Heat or Steam Sterilization
[00889795056276]
Moist Heat or Steam Sterilization
[00889795056276]
Moist Heat or Steam Sterilization
[00889795056276]
Moist Heat or Steam Sterilization
[00889795056276]
Moist Heat or Steam Sterilization
[00889795056276]
Moist Heat or Steam Sterilization
[00889795056276]
Moist Heat or Steam Sterilization
[00889795056276]
Moist Heat or Steam Sterilization
[00889795056276]
Moist Heat or Steam Sterilization
[00889795056276]
Moist Heat or Steam Sterilization
[00889795056276]
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 |
| 00889795057594 | Silverback, Ankle Fusion, Lower Implant Tray |
| 00889795057129 | 14 x 7 Subtalar Trial |
| 00889795057112 | 16 x 8 Subtalar Trial |
| 00889795057105 | 10 x 5 Subtalar Trial |
| 00889795057099 | 16mm Calc-Cuboid Trial Assembly |
| 00889795057082 | 14mm Calc-Cuboid Trial Assembly |
| 00889795057075 | 8mm Calc-Cuboid Trial Assembly |
| 00889795057068 | Subtalar Handle |
| 00889795057051 | Subtalar Coin Correction Guide |
| 00889795057044 | 12mm Calc-Cuboid Trial Assembly |
| 00889795057037 | 19 MM X 20 MM MTP DISC TRIAL HANDLE |
| 00889795057020 | 19 MM X 15 MM MTP DISC TRIAL HANDLE |
| 00889795057013 | 10 MM X 21 MM MTP DISC TRIAL HANDLE |
| 00889795057006 | 5 MM X 21 MM MTP DISC TRIAL HANDLE |
| 00889795056993 | 10 MM X 18 MM MTP DISC TRIAL HANDLE |
| 00889795056986 | 8 MM X 19 MM MTP DISC TRIAL HANDLE |
| 00889795056979 | 5 MM X 19MM MTP DISC TRIAL HANDLE |
| 00889795056962 | 12 MM LAPIDUS, 12 DEGREE, TRIAL HANDLE |
| 00889795056955 | Trial Handle, Lapidus, 8mm |
| 00889795056948 | 5 MM LAPIDUS, 5 DEGREE, TRIAL HANDLE |
| 00889795056856 | Foot Plate, Plantigrade Guide, Radiolucent, v 1.5 |
| 00889795056702 | Shannon-Style Bone Burr, 3.0mm |
| 00889795056689 | Bone Graft Harvester Caddy |
| 00889795056672 | K-Wire, Single Ended Trocar Tip, Threaded, 2.5 x 150mm |
| 00889795056665 | Caspar Type Compression/Distraction Device |
| 00889795056641 | Lobster Claw, Closed |
| 00889795056634 | R3LEASE Device, 3.9 X 48mm, 17mm Notch |
| 00889795056627 | R3LEASE Device, 3.9 X 48mm, 14mm Notch |
| 00889795056450 | Anterior Plates, Ball Tip Wire Guide |
| 00889795056443 | Gorilla R3con Drill Guide, Off Axis |
| 00889795056436 | Gorilla R3con Drill Guide, Easy Guide, 2.7/3.5 |
| 00889795056429 | Gorilla R3con Drill Guide, 4.2 MM |
| 00889795056412 | Centering Drill Guide 3.5mm, TUFFNEK |
| 00889795056405 | Centering Drill Guide 4.2mm, TUFFNEK |
| 00889795056399 | Gorilla R3con Drill Guide, Off Axis |
| 00889795056382 | PROMO Cutting Jig |
| 00889795056375 | Ø5.5mm Tissue Protector, Lateral Column Fusion |
| 00889795056368 | Baby Gorilla, Implant Caddy Lid, Mini |
| 00889795056351 | Baby Gorilla, Talus Fx. Plating System, Caddy Base |
| 00889795056344 | Baby Gorilla Insertion Guide, Threaded |
| 00889795056337 | Gorilla R3CON Drill Guide, 4.2mm |
| 00889795056320 | Threaded Knob, M3 (Template Set Screw) |
| 00889795056313 | BABY GORILLA Plate Caddy, Straight, L, T (Full Module) |
| 00889795056306 | BABY GORILLA Plate Caddy, Oblique L, T, Y (Full Module) |
| 00889795056290 | BABY GORILLA Instrument Caddy (Full Module) |
| 00889795056283 | PROMO Screw Caddy Instruments Base (Use lid 3108-1) |
| 00889795056276 | PROMO Screw Caddy Lid |
| 00889795056269 | PROMO Screw Caddy Base (Use lid 3108-1) |
| 00889795056252 | PROMO Case Base, Full Din |
| 00889795056245 | PROMO Instrument Tray (Insert) |