FDA.reportPublic FDA data

VYRSA General Instrument

Primary DI
G418VYPR1250190
Brand
VYRSA General Instrument
Company
Vyrsa Technologies
Model
VYPR-125-019
Device description
"Ø6mm x 190mm Drill Bit 1/4"" Quick Connect"
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
HTWBit, Drill

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G418VYPR1250190PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, reusableA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. 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
00190776400552MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776400576MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776400644MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776402075MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776402082MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776402204MillenniumAvalign Technologies, Inc.HTW2026-07-19
00190776400293MillenniumAvalign Technologies, Inc.HTW2026-07-17
18257200076536CETRAOrthofix US LLCHTW2026-07-17
18257200076574CETRAOrthofix US LLCHTW2026-07-17
18257200131211Firebird SI FusionOrthofix US LLCHTW2026-07-17
18257200131228Firebird SI FusionOrthofix US LLCHTW2026-07-17
18257200131273Firebird SI FusionOrthofix US LLCHTW2026-07-17
18257200163823PILLAR SA TiOrthofix US LLCHTW2026-07-17
18257200163854PILLAR SA TiOrthofix US LLCHTW2026-07-17
07630008439866APTUSMedartis AGHTW2026-07-16
07630037811374APTUSMedartis AGHTW2026-07-16
09353903030225OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDHTW2026-07-15
09353903030317OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDHTW2026-07-15
09353903030324OCTOPi Suture Anchor SystemFIELD ORTHOPAEDICS PTY LTDHTW2026-07-15
00190776395438MillenniumAvalign Technologies, Inc.HTW2026-07-13
00190446932406Arsenal FootTrilliant Surgical, LLCHTW2026-06-25
00190446948216Arsenal FootTrilliant Surgical, LLCHTW2026-06-25
00190446948483Arsenal FootTrilliant Surgical, LLCHTW2026-06-25
09353903030218Griplasty SystemFIELD ORTHOPAEDICS PTY LTDHTW2026-06-24
00889795154507Spider Monkey Bone Transport SystemParagon 28, Inc.HTW2026-06-10
00889795154514Spider Monkey Bone Transport SystemParagon 28, Inc.HTW2026-06-10
00889795154521Spider Monkey Bone Transport SystemParagon 28, Inc.HTW2026-06-10
00889795154606Spider Monkey Bone Transport SystemParagon 28, Inc.HTW2026-06-10
08800089483433Drill bitJeil Medical CorporationHTW2026-06-10
08800089483457Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationHTW2026-06-10