FDA.reportPublic FDA data

Vilex Guidewire

Primary DI
00841731120908
Brand
Vilex Guidewire
Company
VILEX IN TENNESSEE, INC.
Model
K625-25BE
Catalog number
K625-25BE
Device description
Guidewire FUZE W/Ball 2.5x650mm
Published
2018-08-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
HXIPasser, Wire, Orthopedic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXIPasser, Wire, OrthopedicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841731120908PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841731120908008417311209088417311209080841731120908

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone wireA wire intended for the fixation of bone fractures that may be implanted or used short-term (e.g., to hold a plate in the correct position during an intervention). It may be used: 1) as a cerclage wire to aid bone fixation; 2) in a loop or figure-of-eight configuration to reattach, e.g., the tip of the elbow (olecranon), tibial tubercle, or greater trochanter; 3) to augment bone screw/plate fixation; or 4) as a Kirschner wire or K-Wire to stiffen (arthrodese) a toe or finger. It is made of metal [e.g., stainless steel, cobalt-chrome (Co-Cr)], and may be malleable or rigid; some types include a nut designed to be attached to the wire to prevent wire migration. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
152008371
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
00841731120274Vilex GuidewireK100-09DK100-09D2018-08-06
00841731120281Vilex GuidewireK100-09GK100-09G2018-08-06
00841731120298Vilex GuidewireK100-09SK100-09S2018-08-06
00841731120304Vilex GuidewireK100-11DK100-11D2018-08-06
00841731120311Vilex GuidewireK100-11PTK100-11PT2018-08-06
00841731120328Vilex GuidewireK100-11SK100-11S2018-08-06
00841731120335Vilex GuidewireK100-12SK100-12S2018-08-06
00841731120342Vilex GuidewireK100-14SK100-14S2018-08-06
00841731120359Vilex GuidewireK100-16DK100-16D2018-08-06
00841731120366Vilex GuidewireK100-16SK100-16S2018-08-06
00841731120373Vilex GuidewireK100-20SK100-20S2018-08-06
00841731120441Vilex Plate GuidewireK11-60TK11-60T2018-08-08
00841731120465Vilex GuidewireK150-09DK150-09D2018-08-08
00841731120472Vilex GuidewireK150-11DK150-11D2018-08-08
00841731120489Vilex GuidewireK150-11PTK150-11PT2018-08-08
00841731120496Vilex GuidewireK150-11SK150-11S2018-08-08
00841731120502Vilex GuidewireK150-12DK150-12D2018-08-08
00841731120519Vilex GuidewireK150-12SK150-12S2018-08-08
00841731120526Vilex GuidewireK150-14DK150-14D2018-08-08
00841731120533Vilex GuidewireK150-14SK150-14S2018-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00841731142870TITANEX VILEX LLCHXI2026-05-15
00841731142887TITANEX VILEX LLCHXI2026-05-15
00841731146717TITANEXVILEX LLCHXI2026-05-15
00841731146724TITANEXVILEX LLCHXI2026-05-15
00841731146731TITANEXVILEX LLCHXI2026-05-15
00841731147141TITANEX VILEX LLCHXI2026-05-15
00889795152671Monkey Rings™ External Fixation SystemParagon 28, Inc.HXI2026-05-06
00889795152688Monkey Rings™ External Fixation SystemParagon 28, Inc.HXI2026-05-06
00889795152695Monkey Rings™ External Fixation SystemParagon 28, Inc.HXI2026-05-06
B8034803860ORTHOMEDORTHO-MED, INC.HXI2026-04-16
B8034803880ORTHOMEDORTHO-MED, INC.HXI2026-04-16
00840311246830Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.HXI2026-03-18
10810128462645Nitinol Loop Passer MEDACTAT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHXI2026-02-09
00841731134769Hintermann Series VILEX LLCHXI2026-01-16
06974940306369endophixSuzhou Endophix Co., Ltd.HXI2025-12-12
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