Vilex Guidewire

Primary DI
00841731120519
Brand
Vilex Guidewire
Company
VILEX IN TENNESSEE, INC.
Model
K150-12S
Catalog number
K150-12S
Device description
Guidewire 1.2x150mm Sgl Trocar
Published
2018-08-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
00841731120519PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841731120519008417311205198417311205190841731120519

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00841731118868OrthexR100-2802019-07-18
00841731118899OrthexC351-M4-012019-07-25
00841731118905OrthexC351-M4-022019-07-25
00841731118912OrthexC351-M4-032019-07-25
00841731118929OrthexC351-M4-042019-07-25
00841731118936OrthexC351-M4-052019-07-25
00841731118943Orthex ToolCB-075B2019-07-26
00841731118950Orthex ToolCB-095B2019-07-26
00841731118967Orthex ToolCB-110B2019-07-26
00841731118974Orthex ToolCB-130B2019-07-26
00841731121486Orthex ToolRB-105B2019-07-26
00841731121493Orthex ToolRB-130B2019-07-26
00841731121509Orthex ToolRB-155B2019-07-26
00841731121516Orthex ToolRB-180B2019-07-26
00841731121523Orthex ToolRB-205B2019-07-26
00841731121530Orthex ToolRB-230B2019-07-26
00841731123275OrthexR050-2052019-10-10
00841731123367OrthexCS-12-12019-12-13
00841731123374OrthexCS-12-22019-12-13

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