restor3d Disposable Instrument, Wedge Trial

GUDID 00840097504568

Disposable Trial, Subtalar Wedge, Small Footprint, 10 mm thickness, 0 degree

Restor3d

Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use Surgical implant/trial-implant/sizer holder, single-use
Primary Device ID00840097504568
NIH Device Record Key587b0959-688b-4511-8f8a-4a853935a395
Commercial Distribution StatusIn Commercial Distribution
Brand Namerestor3d Disposable Instrument, Wedge Trial
Version Model Number6105-2719100005
Company DUNS080819836
Company NameRestor3d
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
GS100840097504568 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-04-04
Device Publish Date2022-03-25

On-Brand Devices [restor3d Disposable Instrument, Wedge Trial]

00840097502571Disposable Trial, Cotton Wedge 001, Medium Footprint, 6mm Thickness
00840097502564Disposable Trial Cotton Wedge 001, Medium Footprint,5mm Thickness
00840097502557Disposable Trial, Cotton Wedge 001, Medium Footprint, 4mm Thickness
00840097502540Disposable Trial, Cotton Wedge 001, Small Footprint, 6mm Thickness
00840097502533Disposable Trial, Cotton Wedge 001, Small Footprint, 5mm Thickness
00840097502526Disposable Trial, Cotton Wedge 001, Small Footprint, 4mm Thickness
00840097501611Disposable Trial, Evans Wedge, Large Footprint, 12mm Thickness
00840097501604Disposable Trial, Evans Wedge, Large Footprint, 10mm Thickness
00840097501598Disposable Trial, Evans Wedge, Large Footprint, 8mm Thickness
00840097501581Disposable Trial, Evans Wedge, Medium Footprint, 10mm Thickness
00840097501574Disposable Trial, Evans Wedge, Medium Footprint, 12mm Thickness
00840097501567Disposable Trial, Evans Wedge, Medium Footprint, 8mm Thickness
00840097501550Disposable Trial, Evans Wedge, Small Footprint, 12mm Thickness
00840097501543Disposable Trial, Evans Wedge, Small Footprint, 10mm Thickness
00840097501536Disposable Trial, Evans Wedge, Small Footprint, 8mm Thickness
00840097501420Disposable Trial, Cotton Wedge, Medium Footprint, 4mm Thickness
00840097501413Disposable Trial, Cotton Wedge, Medium Footprint, 5mm Thickness
00840097501406Disposable Trial, Cotton Wedge, Medium Footprint, 4mm Thickness
00840097501390Disposable Trial, Cotton Wedge, Small Footprint, 6mm Thickness
00840097501383Disposable Trial, Cotton Wedge, Small Footprint, 5mm Thickness
00840097501376Disposable Trial, Cotton Wedge, Small Footprint, 4mm Thickness
00840097502984Disposable Trial, Evans Wedge 009, Medium Footprint, 12mm Thickness
00840097502977Disposable Trial, Evans Wedge 009, Large Footprint, 12mm Thickness
00840097502960Disposable Trial, Evans Wedge 009, Large Footprint, 10mm Thickness
00840097502953Disposable Trial, Evans Wedge 009, Large Footprint, 8mm Thickness
00840097502946Disposable Trial, Evans Wedge 009, Medium Footprint, 10mm Thickness
00840097502939Disposable Trial, Evans Wedge 009, Medium Footprint, 8mm Thickness
00840097502922Disposable Trial, Evans Wedge 009, Small Footprint, 12mm Thickness
00840097502915Disposable Trial, Evans Wedge 009, Small Footprint, 10mm Thickness
00840097502908Disposable Trial, Evans Wedge 009, Small Footprint, 8mm Thickness
00840097502762Disposable Trial, Cotton Wedge 002, Anatomic Footprint, 8mm Thickness
00840097502755Disposable Trial, Cotton Wedge 002, Anatomic Footprint, 6mm Thickness
00840097502748Disposable Trial, Cotton Wedge 002, Anatomic Footprint, 5mm Thickness
00840097502731Disposable Trial, Cotton Wedge 002, Anatomic Footprint, 4mm Thickness
00840097503233Non-Sterile Disposable Instrument, Evans Wedge, Double Sided, Large Footprint, 10/12mm Thickness
00840097503226Non-Sterile Disposable Instrument, Evans Wedge, Double Sided, Large Footprint, 08/10mm Thickness
00840097503219Non-Sterile Disposable Instrument, Evans Wedge, Double Sided, Medium Footprint, 10/12mm Thicknes
00840097503202Non-Sterile Disposable Instrument, Evans Wedge, Double Sided, Medium Footprint, 8/10mm Thickness
00840097503196Non-Sterile Disposable Instrument, Evans Wedge, Double Sided, Small Footprint, 10/12mm Thickness
00840097503189Non-Sterile Disposable Instrument, Evans Wedge, Double Sided, Small Footprint, 8/10mm Thickness
00840097503172Non-Sterile Disposable Instrument, Cotton Wedge 002, Double Sided, 9/10mm Thickness
00840097503165Non-Sterile Disposable Instrument, Cotton Wedge 002, Double Sided, 7/8mm Thickness
00840097503158Non-Sterile Disposable Instrument, Cotton Wedge 002, Double Sided, 5/6mm Thickness
00840097503141Non-Sterile Disposable Instrument, Cotton Wedge, Double Sided, Medium Footprint 5/6mm Thickness
00840097503134Non-Sterile Disposable Instrument, Cotton Wedge, Double Sided, Medium Footprint, 4/5mm Thickness
00840097503127Non-Sterile Disposable Instrument, Cotton Wedge, Double Sided, Small Footprint, 5/6mm Thickness
00840097503110Non-Sterile Disposable Instrument, Cotton Wedge, Double Sided, Small Footprint, 4/5mm Thickness
00840097504636Titanium (Ti-6Al-4V) Subtalar Wedge, Left Foot, Large Footprint, 14mm Thickness, 5 Degree
00840097504629Disposable Trial, Subtalar Wedge, Large Footprint, 14 mm thickness, 0 degree
00840097504612Disposable Trial, Subtalar Wedge, Large Footprint, 10 mm thickness, 10 degree

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