FDA.reportPublic FDA data

VirtuGuide

Primary DI
00810112596267
Brand
VirtuGuide
Company
CROSSROADS EXTREMITY SYSTEMS
Model
7000-JRW4
Catalog number
7000-JRW4
Device description
VirtuGuide instruments are used with MotoBAND CP Implant System.The MotoBAND® CP Implant System is indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. When used for these indications, the MotoBAND® CP Implant System with the exception of the 2-hole plate may be used with the MotoCLIP®/HiMAX® Implant System.
Published
2023-03-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FZXGuide, Surgical, Instrument
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810112596267PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810112596267008101125962678101125962670810112596267

GMDN Terms#

Term, Definition table
TermDefinition
Bone awl, reusableA spike-like, manual, orthopaedic surgical instrument intended to bore holes in bone. It is a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end, typically made of metallic and/or synthetic material. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
058864308
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810112592924TriLeap Lower Extremity Anatomic Plating System2.0 mm Ti Cortex Screw Length 13 mm, Blue04.901.0132024-02-21
00810112595758TriLeap Lower Extremity Anatomic Plating System1st MTP Ti Fusion Revision Plate, Medium, 5 Deg, L04.900.0192024-02-16
00810112592443TriLeap Lower Extremity Anatomic Plating SystemLapidus Screw Targeting Guide Left03.900.3982024-02-23
00810112596748TriLeap Lower Extremity Anatomic Plating System04.900.146049001462026-02-13
00810112596779TriLeap Lower Extremity Anatomic Plating System04.900.149049001492026-02-13
00810112598063MOTOBAND InstrumentsVIRTUGUIDE 0 RAC ROTATION - 10° - RT380004R-NSPKG2024-08-01
00810112598421MOTOBAND InstrumentsVIRTUGUIDE 1 RAC ROTATION - 5° - LT380006L-NSPKG2024-08-01
00815432022878MotoBANDMotoBAND CP, Non-Locking Screw, 3.5mm x 18mm - Ste1500-35182016-04-26
00810112593839TriLeap Lower Extremity Anatomic Plating System3.0 mm Ti Variable Angle Screw Length 9 mm, Gold04.906.0092024-02-22
00810112594669TriLeap Lower Extremity Anatomic Plating System3.5 mm Ti Cortex Screw Length 32 mm, Dark Purple04.909.0322024-02-22
00810112595871TriLeap Lower Extremity Anatomic Plating System1st & 2nd Ti Lisfranc Joint Fusion Plate, Medium, 04.900.0332024-02-16
00815432026241HiMAX C7115-1515-C7115-1515-C2022-01-04
00815432029563MotoBANDImplant, 3.5mm x 34mm Anti-Drift Bolt, Fully Threa15FT-35342021-12-17
00815432022069CrossTIE™ 3.0mm 0Deg w/ Universal Inserter1443-33012016-03-09
00815432025459MotoBANDMotoBAND CP, Non-Locking Screw, 3mm x 28mm - Steri15NL-30282018-07-02
00815432026258HiMAX C7115-1818-C7115-1818-C2022-01-04
00815432028801MotoBANDImplant, 3.5mm x 32mm Anti-Drift Bolt15LP-35322020-05-27
00815432028818MotoBANDImplant, 3.5mm x 34mm Anti-Drift Bolt15LP-35342020-05-27
00815432028825MotoBANDImplant, 3.5mm x 36mm Anti-Drift Bolt15LP-35362020-05-27
00815432028832MotoBANDImplant, 3.5mm x 38mm Anti-Drift Bolt15LP-35382020-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327007114ES2 SPINAL SYSTEMStryker CorporationLXH2019-11-25
07613327007558XIA 3Stryker CorporationLXH2019-11-25
07613327007565XIA 3Stryker CorporationLXH2019-11-25
07613327114881XIA 4.5 EVOLUTIONStryker CorporationLXH2019-11-25
07613327121919XIA 4.5 EVOLUTIONStryker CorporationLXH2019-11-25
07613327126273AVS Anchor-C Cervical Cage SystemStryker CorporationLXH2019-11-25
07613327142662XIA 4.5 EVOLUTIONStryker CorporationLXH2019-11-25
07613327142679XIA 4.5 EVOLUTIONStryker CorporationLXH2019-11-25
07613327177480OASYSStryker CorporationLXH2019-11-25
07613327261752DIAPASONStryker CorporationLXH2019-11-25
07613327261943O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327261950O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327261967O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327261974O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327261998O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262001O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262018O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262025O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262032O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262049O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262056O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262070O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262087O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262094O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262100CENTAURStryker CorporationLXH2019-11-25
07613327262285XIAStryker CorporationLXH2019-11-25
07613327263176XIA IIStryker CorporationLXH2019-11-25
07613327263183XIA IIStryker CorporationLXH2019-11-25
07613327263190XIA IIStryker CorporationLXH2019-11-25
07613327263220XIA IIStryker CorporationLXH2019-11-25