| Primary Device ID | G418VYFI5010010 |
| NIH Device Record Key | b1fd64a0-e8eb-4e17-8ef2-ccf8a90105e5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VYRSA General Instrument |
| Version Model Number | VYFI-501-001 |
| Company DUNS | 083331321 |
| Company Name | Vyrsa Technologies |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 |
|---|---|
| HIBCC | G418VYFI5010010 [Primary] |
| FSM | Tray, Surgical, Instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[G418VYFI5010010]
Moist Heat or Steam Sterilization
[G418VYFI5010010]
Moist Heat or Steam Sterilization
[G418VYFI5010010]
Moist Heat or Steam Sterilization
[G418VYFI5010010]
Moist Heat or Steam Sterilization
[G418VYFI5010010]
Moist Heat or Steam Sterilization
[G418VYFI5010010]
Moist Heat or Steam Sterilization
[G418VYFI5010010]
Moist Heat or Steam Sterilization
[G418VYFI5010010]
Moist Heat or Steam Sterilization
[G418VYFI5010010]
Moist Heat or Steam Sterilization
[G418VYFI5010010]
Moist Heat or Steam Sterilization
[G418VYFI5010010]
Moist Heat or Steam Sterilization
[G418VYFI5010010]
Moist Heat or Steam Sterilization
[G418VYFI5010010]
Moist Heat or Steam Sterilization
[G418VYFI5010010]
Moist Heat or Steam Sterilization
[G418VYFI5010010]
Moist Heat or Steam Sterilization
[G418VYFI5010010]
Moist Heat or Steam Sterilization
[G418VYFI5010010]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-02-05 |
| Device Publish Date | 2024-01-27 |
| G418VYV1504070 | Ram Ring, Shipping Lug |
| G418VYV15010010 | VYRSA V1 - Tray |
| G418VYV14000010 | VYRSA Implant Caddy Assembly |
| G418VYV11370900 | 9mm Trial Rasp |
| G418VYV11360900 | Box Chisel |
| G418VYV11350010 | Drill Guide |
| G418VYV11340010 | Working Cannula |
| G418VYV11330010 | Utility Tool |
| G418VYV11311040 | Dilator |
| G418VYV11251520 | Ø6mm – 152mm Drill Bit 1/4" Quick Connect |
| G418VYV11251420 | Ø6mm – 142mm Drill Bit 1/4" Quick Connect |
| G418VYV11251320 | Ø6mm – 132mm Drill Bit 1/4" Quick Connect |
| G418VYV11033250 | SI Extended T10-AO Locking Driver |
| G418VYV11033230 | Short Anchor Deployment Ram |
| G418VYV1103321040 | Short Linkage Bar |
| G418VYV11031250 | SI Locking Driver |
| G418VYV11031230 | SI Deployment Ram |
| G418VYV1103121030 | Knob |
| G418VYV11000010 | AO Straight Handle, Torque Limiting 0.8 Nm |
| G418VYPR5010010 | VYRSA Pro Tray |
| G418VYPR1310010 | Dilator / Joint Finder |
| G418VYPR1300050 | Ø2mm x 190mm Steinmann Pin Round Tip (SS) |
| G418VYPR1300020 | Bailey Joint Finder |
| G418VYPR1250210 | Ø6mm x 210mm Drill Bit 1/4" Quick Connect |
| G418VYPR1250200 | Ø6mm x 200mm Drill Bit 1/4" Quick Connect |
| G418VYPR1250190 | Ø6mm x 190mm Drill Bit 1/4" Quick Connect |
| G418VYPR1200010 | Spacer Drill Guide |
| G418VYPR1190020 | Working Cannula, Left |
| G418VYPR1190010 | Working Cannula, Right |
| G418VYPR1180010 | Joint Finder Extender / Dilator Extender |
| G418VYPR1110060 | Prolix Welded Box Chisel |
| G418VYPR1070010 | Spacer Tamp |
| G418VYPR1060010 | Rasp |
| G418VYFI5010010 | VYRSA Fix Tray |
| G418VYFI5001100 | 11mm Screw Caddy |
| G418VYFI5000700 | 7mm Screw Caddy |
| G418VYFI1311030 | Quick Connect Pin Positioner |
| G418VYFI1311020 | Pin Positioner |
| G418VYFI1304010 | Ø2.4mm X 400mm Blunt Steinmann Pin |
| G418VYFI1304000 | Ø2.4mm X 400mm Trocar Steinmann Pin |
| G418VYFI1301010 | Ø2.4mm X 230mm Trocar Steinmann Pin |
| G418VYFI1291010 | Depth Gauge |
| G418VYFI1251040 | Drill Bit – 11mm |
| G418VYFI1251010 | Drill Bit – 7mm |
| G418VYFI1191060 | Handle Dilator |
| G418VYFI1191030 | Tertiary Dilator |
| G418VYFI1191020 | Secondary Dilator |
| G418VYFI1191010 | Primary Dilator |
| G418VYFI1171000 | Chuck Adaptor |
| G418VYFI1031020 | Screwdriver – 11mm |