Vilex Jones Fracture Tool

GUDID 00841731123213

Drill/Tap Guide, JF 4.5mmScrews

VILEX IN TENNESSEE, INC.

Surgical drill guide, reusable
Primary Device ID00841731123213
NIH Device Record Keyd2d5defa-8967-454e-8aad-32330e062b5e
Commercial Distribution StatusIn Commercial Distribution
Brand NameVilex Jones Fracture Tool
Version Model NumberJF-Guide-45
Company DUNS152008371
Company NameVILEX IN TENNESSEE, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100841731123213 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841731123213]

Moist Heat or Steam Sterilization


[00841731123213]

Moist Heat or Steam Sterilization


[00841731123213]

Moist Heat or Steam Sterilization


[00841731123213]

Moist Heat or Steam Sterilization


[00841731123213]

Moist Heat or Steam Sterilization


[00841731123213]

Moist Heat or Steam Sterilization


[00841731123213]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-02
Device Publish Date2019-08-23

On-Brand Devices [Vilex Jones Fracture Tool]

00841731123244Guide, Jones Fracture Wire
00841731123237Drill/Tap Guide, JF 6.0mm Screws
00841731123220Drill/Tap Guide, JF 5.5mmScrews
00841731123213Drill/Tap Guide, JF 4.5mmScrews
00841731123251Depth Gauge, Jone Fracture 200mm
00841731123206Driver, Jones T20 Hexalobe, Solid, Non Self Retaining
00841731123190Driver, Jones T20 Hexalobe, Non Self Retaining
00841731123183Driver, Jones T20 Hexalobe, Solid Self Retaining
00841731123176Driver, Jones, Hexalobe T20, Self Retaining
00841731123169Countersink, Jones Fracture 6.0mm
00841731123152Countersink, Jones Fracture 5.5mm
00841731123145Countersink, Jones Fracture 4.5mm
00841731123138Tap, Jones Fracture, 6.0mm
00841731123121Tap, Jones Fracture, 5.5mm
00841731123114Tap, Jones Fracture, 4.5mm

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