Goblin Pedicle Screw System FCL-35042

GUDID 00810088653506

Medium 35-42

Medynus, Inc

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00810088653506
NIH Device Record Key2329c6f1-5cf1-4f77-813a-4173e9d94ca6
Commercial Distribution StatusIn Commercial Distribution
Brand NameGoblin Pedicle Screw System
Version Model NumberFCL-35042
Catalog NumberFCL-35042
Company DUNS094374525
Company NameMedynus, Inc
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 Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810088653506 [Primary]

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810088653506]

Moist Heat or Steam Sterilization


[00810088653506]

Moist Heat or Steam Sterilization


[00810088653506]

Moist Heat or Steam Sterilization


[00810088653506]

Moist Heat or Steam Sterilization


[00810088653506]

Moist Heat or Steam Sterilization


[00810088653506]

Moist Heat or Steam Sterilization


[00810088653506]

Moist Heat or Steam Sterilization


[00810088653506]

Moist Heat or Steam Sterilization


[00810088653506]

Moist Heat or Steam Sterilization


[00810088653506]

Moist Heat or Steam Sterilization


[00810088653506]

Moist Heat or Steam Sterilization


[00810088653506]

Moist Heat or Steam Sterilization


[00810088653506]

Moist Heat or Steam Sterilization


[00810088653506]

Moist Heat or Steam Sterilization


[00810088653506]

Moist Heat or Steam Sterilization


[00810088653506]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-15
Device Publish Date2021-10-07

On-Brand Devices [Goblin Pedicle Screw System]

00810088652219Open Ti Str 30
00810088653520X Large 57-86
00810088653513Large 42-57
00810088653506Medium 35-42
00810088653490Small 31-34
00810088653179Open CC Str 500
00810088653162Open CC Str 400
00810088653155Open CC Str 300
00810088653148Open CC Str 200
00810088653094Open CC Str 150
00810088652790Open Ti Cvd 150
00810088652776Open Ti Cvd 140
00810088652752Open Ti Cvd 130
00810088652738Open Ti Cvd 120
00810088652714Open Ti Cvd 110
00810088652691Open Ti Cvd 100
00810088652684Open Ti Cvd 95
00810088652677LCV-55090
00810088652660Open Ti Cvd 85
00810088652653Open Ti Cvd 80
00810088652646Open Ti Cvd 75
00810088652639Open Ti Cvd 70
00810088652622Open Ti Cvd 65
00810088652615Open Ti Cvd 60
00810088652608Open Ti Cvd 55
00810088652592Open Ti Cvd 50
00810088652585Open Ti Cvd 45
00810088652578Open Ti Cvd 40
00810088652561Open Ti Cvd 35
00810088652530Open Ti Str 500
00810088652523Open Ti Str 400
00810088652516Open Ti Str 300
00810088652509Open Ti Str 200
00810088652455Open Ti Str 150
00810088650475Regular 7.5 * 55
00810088650468Regular 7.5 * 50
00810088650451Regular 7.5 * 45
00810088650444Regular 7.5 * 40
00810088650253Regular 6.5 * 55
00810088650246Regular 6.5 * 50
00810088650239Regular 6.5 * 45
00810088650222Regular 6.5 * 40
00810088650215Regular 6.5 * 35
00810088650154Regular 5.5 * 50
00810088650147Regular 5.5 * 45
00810088650130Regular 5.5 * 40
00810088650123Regular 5.5 * 35
00810088654787Regular Cannulated 7.5 * 55
00810088654770Regular Cannulated 7.5 * 50
00810088654763Regular Cannulated 7.5 * 45

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