FDA.reportPublic FDA data

VYRSA General Instrument

Primary DI
G418VYPR1310010
Brand
VYRSA General Instrument
Company
Vyrsa Technologies
Model
VYPR-131-001
Device description
Dilator / Joint Finder
Published
2024-01-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FZXGuide, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G418VYPR1310010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
083331321
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G418VY1000501800VYRSA General Instrument VY-100-05-01802024-01-27
G418VY1050010VYRSA General Instrument VY-105-0012024-01-27
G418VYPR1030020VYRSA ProVYPR-103-0022024-01-27
G418VYPR1030080VYRSA ProVYPR-103-0082024-01-27
G418VYPR1030090VYRSA ProVYPR-103-0092024-01-27
G418VYV11031210VYRSA V1VYV1-103-1212024-01-27
G418VYV1103121040VYRSA V1VYV1-103-121-042024-01-27
G418VYV11033210VYRSA V1VYV1-103-3212024-01-27
G418VYV1232608090VYRSA V1VYV1-2326-08092024-01-27
G418VYV1232608110VYRSA V1VYV1-2326-08112024-01-27
G418VYV1232608130VYRSA V1VYV1-2326-08132024-01-27
G418VY100330VYRSA General Instrument VY-100-332024-01-27
G418VY100340VYRSA General Instrument VY-100-342024-01-27
G418VY1010010VYRSA General Instrument VY-101-0012024-01-27
G418VY1040980VYRSA General Instrument VY-104-0982024-01-27
G418VY5000010VYRSA General InstrumentVY-500-0012024-01-27
G418VYFI070300VYRSA FixVYFI-07-0302024-01-27
G418VYFI070350VYRSA FixVYFI-07-0352024-01-27
G418VYFI070400VYRSA FixVYFI-07-0402024-01-27
G418VYFI070450VYRSA FixVYFI-07-0452024-01-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250337121053Endoscope Adapter for iLESSYS® Delta LaminoscopeJoimax GmbHFZX2026-10-29
04250337121060Coupling nut for endoscope adapterJoimax GmbHFZX2026-10-29
04250337121077Adapter holderJoimax GmbHFZX2026-10-29
04250337121183Locking screw for endoscope adapterJoimax GmbHFZX2026-10-29
04250337122425Endoscope Adapter for LaminoscopeJoimax GmbHFZX2026-10-29
M739985202229Marking PinCAPTIVA SPINE, INC.FZX2026-10-28
M739985203229Marking PinCAPTIVA SPINE, INC.FZX2026-10-28
00889024702295OsseoFitZimmer, Inc.FZX2026-10-27
00889024702301OsseoFitZimmer, Inc.FZX2026-10-27
04250337119210Counter Pusher, greenJoimax GmbHFZX2026-10-27
04250337119227Counter Pusher, yellowJoimax GmbHFZX2026-10-27
04250337119234Counter Pusher, redJoimax GmbHFZX2026-10-27
M209232940Rose Proximal Cutting GuideBIOPRO, INC.FZX2026-10-27
M20923295Rose Distal Cutting GuideBIOPRO, INC.FZX2026-10-27
M739985202530Marking PinCAPTIVA SPINE, INC.FZX2026-10-23
M739985203530Marking PinCAPTIVA SPINE, INC.FZX2026-10-23
04250337117933Punching Adapter for Working TubeJoimax GmbHFZX2026-10-22
04250337119180Guiding Tube, eccentrically cannulated, redJoimax GmbHFZX2026-10-22
04250337119197Guiding Tube, eccentrically cannulated, purpleJoimax GmbHFZX2026-10-22
04250337119203Working Tube with Handle, oblique 45°Joimax GmbHFZX2026-10-22
04250337119562Guiding Tube, conicalJoimax GmbHFZX2026-10-22
04250337119579Guiding rod , conicalJoimax GmbHFZX2026-10-22
04250337119586Guiding rod , conicalJoimax GmbHFZX2026-10-22
04250337119593Working Tube with crown half teeth tipJoimax GmbHFZX2026-10-22
04250337119647Working Tube with handle, Standard lipJoimax GmbHFZX2026-10-22
04250337119678Guiding rod, conical, longitudinal slantedJoimax GmbHFZX2026-10-22
04250337119791Working Tube with long lipJoimax GmbHFZX2026-10-22
04250337120834Working tube, long lipJoimax GmbHFZX2026-10-22
04250337121862Working Tube with Handle, Standard LipJoimax GmbHFZX2026-10-22
04250337121909Working Tube with Handle, Standard LipJoimax GmbHFZX2026-10-22