FDA.reportPublic FDA data

Vilex Guidewire

Primary DI
00841731120366
Brand
Vilex Guidewire
Company
VILEX IN TENNESSEE, INC.
Model
K100-16S
Catalog number
K100-16S
Device description
Guidewire 1.6x100mm Sgl Trocar
Published
2018-08-06
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
00841731120366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841731120366008417311203668417311203660841731120366

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
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
00841731120540Vilex GuidewireK150-16DK150-16D2018-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841731133588REDEMPTION Beaming SystemVILEX LLCHXI2026-11-03
00841731133595REDEMPTION Beaming SystemVILEX LLCHXI2026-11-03
00842078100127HammerFiXEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078100134HammerFiXEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078100141HammerFiXEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078100295IO FiXEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078100318XMCPEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078101889Jones UnionEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078110126AlignXEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078110263AlignXEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078112267Axis BeamsEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078112281Axis BeamsEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078114735Omni MTPEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078114766Omni MTPEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078116159Omni PlatingEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078116166Omni PlatingEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078116180AlignXEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078119822Axis PlatingEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078123379Omni Stable AFEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078124239Lapidus Joint PrepEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078126066Lapidus Joint PrepEXTREMITY MEDICAL, LLCHXI2026-10-29
00842078137178MetaForeEXTREMITY MEDICAL, LLCHXI2026-10-29
04047844130957DIPLOMATSIGNUS Medizintechnik GmbHHXI2026-10-26
04047844130964DIPLOMATSIGNUS Medizintechnik GmbHHXI2026-10-26
04047844130971DIPLOMATSIGNUS Medizintechnik GmbHHXI2026-08-14
04047844130988DIPLOMATSIGNUS Medizintechnik GmbHHXI2026-08-14
10810128464137WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHXI2026-07-22
00841731135568TITANEX VILEX LLCHXI2026-05-15
00841731137319TITANEX VILEX LLCHXI2026-05-15
00841731137906TITANEXVILEX LLCHXI2026-05-15