Primary Device ID | G418VYPR1310010 |
NIH Device Record Key | 54ecd6c0-6e0c-49b3-b54e-bebaf469276c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | VYRSA General Instrument |
Version Model Number | VYPR-131-001 |
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 | G418VYPR1310010 [Primary] |
FZX | Guide, Surgical, Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[G418VYPR1310010]
Moist Heat or Steam Sterilization
[G418VYPR1310010]
Moist Heat or Steam Sterilization
[G418VYPR1310010]
Moist Heat or Steam Sterilization
[G418VYPR1310010]
Moist Heat or Steam Sterilization
[G418VYPR1310010]
Moist Heat or Steam Sterilization
[G418VYPR1310010]
Moist Heat or Steam Sterilization
[G418VYPR1310010]
Moist Heat or Steam Sterilization
[G418VYPR1310010]
Moist Heat or Steam Sterilization
[G418VYPR1310010]
Moist Heat or Steam Sterilization
[G418VYPR1310010]
Moist Heat or Steam Sterilization
[G418VYPR1310010]
Moist Heat or Steam Sterilization
[G418VYPR1310010]
Moist Heat or Steam Sterilization
[G418VYPR1310010]
Moist Heat or Steam Sterilization
[G418VYPR1310010]
Moist Heat or Steam Sterilization
[G418VYPR1310010]
Moist Heat or Steam Sterilization
[G418VYPR1310010]
Moist Heat or Steam Sterilization
[G418VYPR1310010]
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 |