Vilex Tool CFX-300

GUDID 00841132177914

Orthex Small Bone Drill Tray

ORTHOPEDIATRICS CORP.

Instrument tray
Primary Device ID00841132177914
NIH Device Record Key0fc2abdd-e153-4aa6-aa18-f98254e10823
Commercial Distribution StatusIn Commercial Distribution
Brand NameVilex Tool
Version Model NumberCFX-300
Catalog NumberCFX-300
Company DUNS796416191
Company NameORTHOPEDIATRICS CORP.
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 Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com
Phone+1(574)268-6379
Emailbsmith@orthopediatrics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841132177914 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FSMTRAY, SURGICAL, INSTRUMENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841132177914]

Moist Heat or Steam Sterilization


[00841132177914]

Moist Heat or Steam Sterilization


[00841132177914]

Moist Heat or Steam Sterilization


[00841132177914]

Moist Heat or Steam Sterilization


[00841132177914]

Moist Heat or Steam Sterilization


[00841132177914]

Moist Heat or Steam Sterilization


[00841132177914]

Moist Heat or Steam Sterilization


[00841132177914]

Moist Heat or Steam Sterilization


[00841132177914]

Moist Heat or Steam Sterilization


[00841132177914]

Moist Heat or Steam Sterilization


[00841132177914]

Moist Heat or Steam Sterilization


[00841132177914]

Moist Heat or Steam Sterilization


[00841132177914]

Moist Heat or Steam Sterilization


[00841132177914]

Moist Heat or Steam Sterilization


[00841132177914]

Moist Heat or Steam Sterilization


[00841132177914]

Moist Heat or Steam Sterilization


[00841132177914]

Moist Heat or Steam Sterilization


[00841132177914]

Moist Heat or Steam Sterilization


[00841132177914]

Moist Heat or Steam Sterilization


[00841132177914]

Moist Heat or Steam Sterilization


[00841132177914]

Moist Heat or Steam Sterilization


[00841132177914]

Moist Heat or Steam Sterilization


[00841132177914]

Moist Heat or Steam Sterilization


[00841132177914]

Moist Heat or Steam Sterilization


[00841132177914]

Moist Heat or Steam Sterilization


[00841132177914]

Moist Heat or Steam Sterilization


[00841132177914]

Moist Heat or Steam Sterilization


[00841132177914]

Moist Heat or Steam Sterilization


[00841132177914]

Moist Heat or Steam Sterilization


[00841132177914]

Moist Heat or Steam Sterilization


[00841132177914]

Moist Heat or Steam Sterilization


[00841132177914]

Moist Heat or Steam Sterilization


[00841132177914]

Moist Heat or Steam Sterilization


[00841132177914]

Moist Heat or Steam Sterilization


[00841132177914]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-09
Device Publish Date2020-02-28

On-Brand Devices [Vilex Tool]

00841132180662Pin Cutter, Double Action
00841132180655Wire Cutter & Bending Pliers
00841132180631Wire Cutter & Bending Pliers
00841132180624Rail Tray
00841132180617Strut & Hardware Tray
00841132180600Ring Tray
00841132178751Tray, Orthex Drill
00841132177921Orthex Small Bone Ring Tray
00841132177914Orthex Small Bone Drill Tray
00841132177907Orthex Small Bone Cubes & Struts Tray
00841132177891Orthex Small Bone Hardware Tray
00841132181003Orthex, Hex Driver, 3mm
00841132180990Orthex, Hex Driver, 2mm
00841132180709Tensioner, Short Nose
00841132179932Orthex Sleeve wire SB 3.5x75mm
00841132179925Orthex Sleeve wire SB 3.5x155mm
00841132179918Orthex Sleeve wire SB 2.7x75mm
00841132179901Orthex Sleeve wire SB 2.7x155mm
00841132179895Orthex Sleeve wire SB 2.0x75mm
008411321798574.5 drill sleeve, Short
008411321798404.5 drill sleeve, Long
00841132179833Wire Sleeve 6.0x4.5x100mm
008411321798263.2 drill sleeve, Short
008411321798193.2 drill sleeve, Long
008411321798022.0 drill sleeve, Short
008411321797962.0 drill sleeve, Long

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