Vilex Fibula Tool ZF-D62

GUDID 00841731129987

Tissue Protector, Fibula Nail, 6.2mm

VILEX LLC

Surgical drill guide, reusable
Primary Device ID00841731129987
NIH Device Record Keye40e8605-5301-4cb6-8898-dfa5eaffd7c0
Commercial Distribution StatusIn Commercial Distribution
Brand NameVilex Fibula Tool
Version Model NumberZF-D62
Catalog NumberZF-D62
Company DUNS117502293
Company NameVILEX LLC
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
GS100841731129987 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841731129987]

Moist Heat or Steam Sterilization


[00841731129987]

Moist Heat or Steam Sterilization


[00841731129987]

Moist Heat or Steam Sterilization


[00841731129987]

Moist Heat or Steam Sterilization


[00841731129987]

Moist Heat or Steam Sterilization


[00841731129987]

Moist Heat or Steam Sterilization


[00841731129987]

Moist Heat or Steam Sterilization


[00841731129987]

Moist Heat or Steam Sterilization


[00841731129987]

Moist Heat or Steam Sterilization


[00841731129987]

Moist Heat or Steam Sterilization


[00841731129987]

Moist Heat or Steam Sterilization


[00841731129987]

Moist Heat or Steam Sterilization


[00841731129987]

Moist Heat or Steam Sterilization


[00841731129987]

Moist Heat or Steam Sterilization


[00841731129987]

Moist Heat or Steam Sterilization


[00841731129987]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-04-22
Device Publish Date2022-04-14

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00841731137616 - TITANEX 2026-02-17 TITANEX MICROBEAM 2.0 X 30MM

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