5MS

GUDID 00817906028300

5MS, PLANTAR PLATE, LARGE, TRIAL, 5H

IN2BONES USA, LLC

Orthopaedic implant/trial-implant holder, reusable
Primary Device ID00817906028300
NIH Device Record Key6f24a236-c779-4a22-a858-95ec5b8af52a
Commercial Distribution StatusIn Commercial Distribution
Brand Name5MS
Version Model NumberP06 N1012
Company DUNS079700711
Company NameIN2BONES USA, LLC
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 Batchtrue
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
GS100817906028300 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00817906028300]

Moist Heat or Steam Sterilization


[00817906028300]

Moist Heat or Steam Sterilization


[00817906028300]

Moist Heat or Steam Sterilization


[00817906028300]

Moist Heat or Steam Sterilization


[00817906028300]

Moist Heat or Steam Sterilization


[00817906028300]

Moist Heat or Steam Sterilization


[00817906028300]

Moist Heat or Steam Sterilization


[00817906028300]

Moist Heat or Steam Sterilization


[00817906028300]

Moist Heat or Steam Sterilization


[00817906028300]

Moist Heat or Steam Sterilization


[00817906028300]

Moist Heat or Steam Sterilization


[00817906028300]

Moist Heat or Steam Sterilization


[00817906028300]

Moist Heat or Steam Sterilization


[00817906028300]

Moist Heat or Steam Sterilization


[00817906028300]

Moist Heat or Steam Sterilization


[00817906028300]

Moist Heat or Steam Sterilization


[00817906028300]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-11-22
Device Publish Date2018-10-22

On-Brand Devices [5MS]

008179060283175MS, PLANTAR PLATE, LARGE, TRIAL, 4H
008179060283005MS, PLANTAR PLATE, LARGE, TRIAL, 5H
008179060282945MS, PSEUDO JONES PLATE TRIAL
008179060282875MS, BUNIONETTE PLATE, L, TRIAL
008179060282705MS, BUNIONETTE PLATE, R, TRIAL
008179060282635MS, LATERAL NECK PLATE, 6H, L, TRIAL
008179060282565MS, LATERAL NECK PLATE, 8H, L, TRIAL
008179060282495MS, LATERAL NECK PLATE, 6H, R, TRIAL
008179060282325MS, LATERAL NECK PLATE, 8H, R, TRIAL
008179060282255MS, PLANTAR PLATE, TRIAL, 4H
008179060282185MS, PLANTAR PLATE, TRIAL, 5H
00817906028201COMPRESSION DRILL GUIDE, Ø2.0 & Ø2.5, ASSY
00817906028195COMPRESSION DRILL GUIDE, Ø1.6 & Ø1.9, ASSY
008179060281885MS, PSEUDO JONES PLATE TAMP
008179060281715MS, LOCKING DRILL GUIDE, Ø1.9
008179060281645MS, LOCKING DRILL GUIDE, Ø1.6
008179060281575MS, JONES SCREW SIZER

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