IBS Implant System

GUDID 08800039325462

InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)

Dental implant system
Primary Device ID08800039325462
NIH Device Record Keyc4cc839d-a7cd-4514-9422-f703c172a50a
Commercial Distribution StatusIn Commercial Distribution
Brand NameIBS Implant System
Version Model NumberIBS4515
Company DUNS631169224
Company NameInnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800039325462 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-16
Device Publish Date2024-10-08

On-Brand Devices [IBS Implant System]

08800039325448IBS4511
08800039325431IBS4509
08800039325424IBS4507
08800039325417IBS4015
08800039325400IBS4013
08800039325394IBS4011
08800039325387IBS4009
08800039325370IBS4007
08800039325615IBS6015
08800039325608IBS6013
08800039325592IBS6011
08800039325585IBS6009
08800039325578IBS6007
08800039325561IBS5515
08800039325554IBS5513
08800039325547IBS5511
08800039325530IBS5509
08800039325523IBS5507
08800039325516IBS5015
08800039325509IBS5013
08800039325493IBS5011
08800039325486IBS5009
08800039325479IBS5007
08800039325462IBS4515
08800039325455IBS4513

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