MD Vue Lateral Access 54-FM-1000

GUDID 00840019919623

Fluoromodulator

PRECISION SPINE, INC.

Neurosurgical retraction system, spinal
Primary Device ID00840019919623
NIH Device Record Key51a037fb-f681-43fa-86bd-7962d1fdd6f6
Commercial Distribution StatusIn Commercial Distribution
Brand NameMD Vue Lateral Access
Version Model Number54-FM-1000
Catalog Number54-FM-1000
Company DUNS079398589
Company NamePRECISION SPINE, INC.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
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
GS100840019919623 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840019919623]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-04
Device Publish Date2019-03-27

On-Brand Devices [ MD Vue Lateral Access ]

00840019919708Light Cable Case (Empty)
0084001991967830mm Serial Dilator
0084001991966125mm Serial Dilator
00840019919647Anterior Retractor Bridge, Small
00840019919623Fluoromodulator
00840019919616Cruciform Incision Locator
00840019919609Disposable Bipolar Forceps
00840019919593Bifurcated Illuminator
00840019919586Light Cable
00840019919579Bipolar Forceps - 8" 1mm Straight Tips
00840019919562Penfield Distractor - Bayonetted
00840019919555Penfield Distractor - Long, Straight
00840019919548Penfield Distractor - Short, Straight
00840019919531Suction Instruments - 10 Fr Long
00840019919524Suction Instruments - 8 Fr Long
00840019919517Fixation Pin Driver
00840019919494180mm Wide Anterior Retractor
00840019919487180mm Narrow Anterior Retractor
00840019919470140mm Wide Anterior Retractor
00840019919463140mm Narrow Anterior Retractor
00840019919456Retractor Anterior Arm
00840019919449Posterior Lobe Handle
00840019919432Retractor Handle - Cephalad/Caudal
00840019919425Retractor Body
00840019919418Shim Remover
00840019919401Shim Inserter / Impactor
0084001991939525mm Widening Shim Left
0084001991938825mm Widening Shim Right
0084001991937110mm Lengthening Shim
0084001991934020mm Posterior Shim
00840019919333180mm Posterior Blade
00840019919326170mm Posterior Blade
00840019919319160mm Posterior Blade
00840019919302150mm Posterior Blade
00840019919296140mm Posterior Blade
00840019919272120mm Posterior Blade
00840019919258100mm Posterior Blade
0084001991924190mm Posterior Blade
0084001991923480mm Posterior Blade
00840019919210180mm Left Blade
00840019919203170mm Left Blade
0084001991918054-BL-0150
00840019919173140mm Left Blade
0084001991916654-BL-0130
00840019919159120mm Left Blade
00840019919135100mm Left Blade
0084001991911180mm Left Blade
0084001991910470mm Left Blade
00840019919067150mm Right Blade
00840019919050140mm Right Blade

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