FDA.reportPublic FDA data

VYRSA General Instrument

Primary DI
G418VYPR1300050
Brand
VYRSA General Instrument
Company
Vyrsa Technologies
Model
VYPR-130-005
Device description
Ø2mm x 190mm Steinmann Pin Round Tip (SS)
Published
2024-01-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G418VYPR1300050PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic intraoperative positioning pin, reusableA nonimplantable device in the form of a thin rod intended to be drilled into bone to assist with the positioning of an implantable device and/or surgical instrument (e.g., fixation plate, drill guide) during an orthopaedic procedure. It is also referred to as a wire or temporary K-wire. 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
G418VYPR1310010VYRSA General Instrument VYPR-131-0012024-01-27
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000675028n/aMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-19
00824846002468Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-19
00763000837198Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-18
00199150041183N/AMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00199150076024Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00763000891329Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00840314263636gSourceGSOURCE LLCLXH2026-07-17
00840314264190gSourceGSOURCE LLCLXH2026-07-17
00840314264268gSourceGSOURCE LLCLXH2026-07-17
00840314264404gSourceGSOURCE LLCLXH2026-07-17
00840314264473gSourceGSOURCE LLCLXH2026-07-17
00840314264541gSourceGSOURCE LLCLXH2026-07-17
00840314264619gSourceGSOURCE LLCLXH2026-07-17
00840314264688gSourceGSOURCE LLCLXH2026-07-17
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