restor3d Osteotomy Wedge

GUDID 00840097500140

Titanium (Ti-6AI-4V ELI) Wedge, Evans, Medium Footprint, 12mm Thickness

Restor3d

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Primary Device ID00840097500140
NIH Device Record Keyc19ee592-9539-41a2-9197-677ffa0280cc
Commercial Distribution StatusIn Commercial Distribution
Brand Namerestor3d Osteotomy Wedge
Version Model Number1101-20181218
Company DUNS080819836
Company NameRestor3d
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840097500140 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PLFBone Wedge

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-24
Device Publish Date2019-12-16

On-Brand Devices [restor3d Osteotomy Wedge]

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00840097500294Titanium (Ti-6AI-4V ELI) Wedge, Evans, Large Footprint, 12mm Thickness
00840097500287Titanium (Ti-6AI-4V ELI) Wedge, Evans, Large Footprint, 10mm Thickness
00840097500270Titanium (Ti-6AI-4V ELI) Wedge, Evans, Large Footprint, 8mm Thickness
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00840097500256Titanium (Ti-6AI-4V ELI) Wedge, Evans, Medium Footprint, 12mm Thickness
00840097500249Titanium (Ti-6AI-4V ELI) Wedge, Evans, Medium Footprint, 10mm Thickness
00840097500232Titanium (Ti-6AI-4V ELI) Wedge, Evans, Medium Footprint, 8mm Thickness
00840097500225Titanium (Ti-6AI-4V ELI) Wedge, Evans, Medium Footprint, 6mm Thickness
00840097500218Titanium (Ti-6AI-4V ELI) Wedge, Evans, Small Footprint, 12mm Thickness
00840097500201Titanium (Ti-6AI-4V ELI) Wedge, Evans, Small Footprint, 10mm Thickness
00840097500195Titanium (Ti-6AI-4V ELI) Wedge, Evans, Small Footprint, 8mm Thickness
00840097500188Titanium (Ti-6AI-4V ELI) Wedge, Evans, Small Footprint, 6mm Thickness
00840097500171Titanium (Ti-6AI-4V ELI) Wedge, Evans, Large Footprint, 12mm Thickness
00840097500164Titanium (Ti-6AI-4V ELI) Wedge, Evans, Large Footprint, 10mm Thickness
00840097500157Titanium (Ti-6AI-4V ELI) Wedge, Evans, Large Footprint, 8mm Thickness
00840097500140Titanium (Ti-6AI-4V ELI) Wedge, Evans, Medium Footprint, 12mm Thickness
00840097500133Titanium (Ti-6AI-4V ELI) Wedge, Evans, Medium Footprint, 10mm Thickness
00840097500126Titanium (Ti-6AI-4V ELI) Wedge, Evans, Medium Footprint, 8mm Thickness
00840097500119Titanium (Ti-6AI-4V ELI) Wedge, Evans, Small Footprint, 12mm Thickness
00840097500102Titanium (Ti-6AI-4V ELI) Wedge, Evans, Small Footprint, 10mm Thickness
00840097500096Titanium (Ti-6AI-4V ELI) Wedge, Evans, Small Footprint, 8mm Thickness
00840097500089Titanium (Ti-6AI-4V ELI) Wedge, Cotton, Medium Footprint, 6mm Thickness
00840097500072Titanium (Ti-6AI-4V ELI) Wedge, Cotton, Medium Footprint, 5mm Thickness
00840097500065Titanium (Ti-6AI-4V ELI) Wedge, Cotton, Medium Footprint, 4mm Thickness
00840097500058Titanium (Ti-6AI-4V ELI) Wedge, Cotton, Small Footprint, 6mm Thickness
00840097500041Titanium (Ti-6AI-4V ELI) Wedge, Cotton, Small Footprint, 5mm Thickness
00840097500034Titanium (Ti-6AI-4V ELI) Wedge, Cotton, Small Footprint, 4mm Thickness
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00840097502502Titanium (Ti-6Al-4V) Wedge, Cotton 001, Medium Footprint, 5mm Thickness
00840097502496Titanium (Ti-6Al-4V) Wedge, Cotton 001, Medium Footprint, 4mm Thickness
00840097502489Titanium (Ti-6Al-4V) Wedge, Cotton 001, Small Footprint, 6mm Thickness
00840097502472Titanium (Ti-6Al-4V) Wedge, Cotton 001, Small Footprint, 5mm Thickness
00840097502465Titanium (Ti-6Al-4V) Wedge, Cotton 001, Small Footprint, 4mm Thickness
00840097502892Titanium (Ti-6Al-4V) Evans Wedge 009, Large Footprint, 12mm Thickness
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00840097502854Titanium (Ti-6Al-4V) Evans Wedge 009, Medium Footprint, 10mm Thickness
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00840097502830Titanium (Ti-6Al-4V) Evans Wedge 009, Small Footprint, 12mm Thickness
00840097502823Titanium (Ti-6Al-4V) Evans Wedge 009, Small Footprint, 10mm Thickness
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